/ 1671/ 1652

Message by Medical Director

A great treatment offers benefit to an individual

patient and a good hospital should provide such

good treatment to multitude of patients.

A good research offers solutions to millions of

patients across the globe and is a far more

powerful tool for serving patients than just good

treatment alone.

A great hospital must offer quality research and

hence contribute towards improvements in

treatment options.

Deenanath Mangeshkar Hospital is committed to

make this transition to a great hospital by

undertaking Clinical Research. As a part of

management of Deenanath Mangeshkar Hospital

we are firmly committed to this research endeavor

Dr. Dhananjay Kelkar

Medical Director

Deenanath Mangeshkar Hospital and Research

Centre.

“We need your help. I need your help. We need

your support for research. It may not save

my life. It may save my children's life. It may save

someone you love. And it's very important.”

Jim Valvano

Scientific & Industrial Research Organization

(SIRO) & Dept. of Scientific & Industrial Research

(DSIR), Government of

India, New Delhi.

Research division started in 2002. Research @ DMHRC provides admin support to Institutional Ethics Committee (IEC) and makes sure that the Regulatory requirements are met by the principal Investigator of the Sponsored Clinical Trials & In-house research studies.

Promotes and encourages in-house research in one pathy and more than one pathy .

About Us

Abbreviations Long Form

DMHRC Deenanath Mangeshkar Hospital and Research Centre

IEC Institutional Ethics Committee

SAC Scientific Advisory Committee

SACIR Scientific Advisory Committee for Integrated Research

CCPR Core Committee for Promotion of Research

IERC Institutional Ethical Research Committee

SOP Standard Operating Procedure

SIRO Scientific and Industrial Research Organizations

ICH International Conference on Harmonization

GCP Good Clinical Practice

ICMR Indian Council of Medical Research

NABL National Accreditation Board for Testing and

Calibration Laboratories

Abbreviations

Start of IERC- 2004

Start of Research co-ordination department in 2002

Appointment of SAC -2005

Written first SOP for working of IEC:-May2007

Appointment of CCPR-2008

Renamed as Dept of Research-2009

Received SIRO accreditation - 2009

Clusters of research department: Regulation and Facilitation Dept- 2010

Renewal of SIRO Accreditation -2011

Growth of Research Department

Research Infrastructure

(1) State of Art Laboratory and diagnostic facilities – Our Pathology and Microbiology

laboratory is accredited in accordance with ISO 15189:2007 standard by National Accreditation

Board for Testing and Calibration Laboratories (NABL), Dept. of Science & Technology, Govt. of

India. Other diagnostic facilities include imaging (1.5 Tesla MRI, 64 slice CT scan, USG, digital

radiology etc.) and imaging for cardiovascular purposes viz. Color Doppler, 2 D Echo and

cardiac cathlab. 12-lead ECG is available.

(2) Storage of Biological Material: Samples such as DNA, RNA, Plasma, Serum, Bacterial,

Fungal, microbacterial culture, tissue for Psychopathology can be stored.

(3) Telecommunication - Dedicated high speed telecommunication facilities including internet and

videoconferencing in addition to conventional telephonic and fascimile (fax) transmission.

Medical Records - Facility to Archive Medical Records. Striving towards making the medical

record system paperless (electronic).

(4) Good Human Resource Development & Administrative Set Up - ‘Green channel’ for clinical

trial participants - Express registration, check-in, check-out and utilization of diagnostic facilities.

(5) Strong patient referral network-

Primary source - Clientele of DMHRC from Pune city and adjoining towns and districts

Secondary source - Referral via network of associates (physicians & general practitioners).

(6) Excellent Service provider - By maintaining high standards through recruitment and retention

of excellent staff, physicians, dentists and volunteers.

Department of Research

DEPARTMENT OF RESEARCH

Facilitation Regulation

Assistant director & HOD of research

department

Receive all study

related documents

Communication with PI

and CRCs

Review and evaluate documents

ensuring regulatory compliance as per

ICH-GCP, WHO, Schedule Y and ICMR

guidelines.

Conducts sub committee and ethics

committee meetings. Recording minutes of

the meetings

Encourages In-house research

Help in writing protocol

Study conduct

Designing of questionnaires

&

Analysis of data

Help in writing manuscript Monitoring of ongoing sponsored and In-

house trials

Communication with

CRO / Sponsor

An overview of Sponsored Clinical Trials

61

7277

2 18

19

34

64

0

10

20

30

40

50

60

70

80

90

2002 2003 2004 2005 2006 2007 2008 2009 2010

Year

Nu

mb

er

Figure 1: Number of sponsored Clinical Trials by Year

Figure 2: List of CROs who have sponsored clinical trials

Average 69 trials were conducted per year from 2007 to 2010.

3 3 3 3 4 4 4 5 5 5

5 6

7

10

11 13

51

CHILTERN INTERNATIONAL PVT.LTD. CLINIVENT RESEARCH

PRIVATE LIMITED

PAREXEL INTERNATIONAL GMBH. PHARM-OLAM INTERNATIONAL

CLINIRX I3 RESEARCH

IGATE CLINICAL

RESEARCH INTERNATIONAL

ICON CLINICAL RESEARCH

PHARMANET PPD INTERNATIONAL

PRA INTERNATIONAL SIRO CLINPHARM PVT.LTD

COVANCE INDIA PHARMACEUTICAL

SERVICES PRIVATE LTD.

LAMBDA THERAPEUTIC

RESEARCH LTD.

RELIANCE CLINICAL RESEARCH SERVICES MAX NEEMAN MEDICAL

INTERNATIONAL

QUINTILES RESEARCH INDIA PVT.LTD.

50% of the trials are

conducted by Quintiles &

13% by Max Neeman,

An overview of Sponsored Clinical Trials

30% of the trials are Oncology, 14% Psychiatry & 12% Cardiology.

C

A

R

DI

O

LO

GY

P

S

Y

C

H

I

A

T

R

Y

0.5 0.5

0.8 0.8 1.1 1.4 1.4

1.7 1.7

3.9 5.3

5.7

6.8

10.7 11.6

14.4

29.7

GYNECOLOGY (0.5%) NEPHROLOGY (0.5%)

GASTROENTEROLOGY (0.8%) ORTHOPEDICS (0.8%)

HEMATOLOGY (1.1%) PAEDIATRICS (1.4%)

SURGERY (1.4%) INTENSIVIST (1.7%)

MEDICINE (1.7%) UROLOGY (3.9%)

ENDOSCOPY (5.3%) ENDOCRINOLOGY (5.7%)

NEUROLOGY (6.8%) BIOEQUIVALENCE (10.7)

CARDIOLOGY (11.6%) PSYCHIATRY (14.4%)

ONCOLOGY (29.7%)

Figure 3: Sponsored Clinical Trials by Specialty

O

N

C

O

L

O

G

Y

Maximum number of trials conducted at DMH are in Oncology (30%). 14% trials are in Psychiatry and

about 12% trials are in Cardiology.

In-house studies conducted @ DMHRC 2008 to 2010

Figure 4: Current ongoing and closed in-house studies

Figure 5: Percent of in-house studies from various departments

DMHRC encourages

integrated research i.e.

research involving more

than one pathy. At

present we have five

such on going research

projects.

JPSS (Jana Prabodhini

Shoushodhan Sanstha)

was the main

collaborator for

conducting 5 ongoing &

19 completed projects.

49.32% 50.68%

Ongoing (No.= 36)

Completed (No.=37)

11111112233333

4

44

77

10

6SAC-IR, 5

Anaesthesia Fetal Medicine Neurology NICU

Urology Nutrition Endoscopy Nephrology

Pediatrics Dentistry Orthopedic Genetics

Medicine Cardiology Gynacology Psychiatry

Pathology SAC-IR Opthalmology ICU

Oncology ENT

In terms of percentages, half of the in-house project are observational studies, 16 %

were surgery related and 12% were surveys to study awareness. (2 studies were terminated)

Abstracts of In-House Projects

A single center experience of EUS guided fine needle aspiration

cytology (FNAC) in pancreatic mass lesions

Bapaye A1, Aher A1, Bhide V2, Joshi V2

1Department of Digestive Diseases & Endoscopy,

2Department of Pathology,

Deenanath Mangeshkar Hospital & Research Center, Pune, India

Introduction:

Over a 4 year period (2006 – 10), 110 patients under went endosonography

(EUS) guided FNAC for suspected / confirmed pancreatic mass lesions on

imaging.

Materials and Methods:

EUS was performed using Fujinon SU7000 EUS system and EG530UT linear

echoendoscope (Fuji film Inc., Japan). After locating the lesion by EUS, FNA

as obtained using 22GEchotip-Ultra needle (Cook, USA). Onsite pathologist

was available in 45 patients, 41% (Group 2) whereas was absent in the

remaining 65, 59% (Group 1).

Results:

Overall accuracy in our series was 89%. Cytopathology in 110

samples revealed 35 (31%) adenocarcinoma, 7 (6%) chronic pancreatitis, 7

(6%) pancreatic TB or tubercular peripancreatic lymph nodes, 4 (4%)

neuroendocrine tumors, 3 (3%) solid pseudo papillary epithelial neoplasm

(SPEN), 3 (3%) mucinous cystadenomas and one patient each of papillary

neoplasm and lymphoma. Cytology was inconclusive in 12 (11%) patients.

Adequate samples but not representing any pathology were obtained in 37

(34%) patients. Inconclusive samples were significantly reduced in Group 2

vs. Group 1 – 4/45 (9%) vs. 17/65 26%), p < 0.05.

Conclusions: Adenocarcinoma was seen only in 31% patients. Benign

conditions were seen in 14%.Surgery could be avoided in 14%

patients. Presence of onsite pathologist significantly improved yield of EUS

guided FNA. Abstract presented as poster during Asia Pacific Digestive Week 2010,

Kuala Lumpur

.

Endoscopic management of pancreatic pseudocysts – just drain the cyst or

combine with ductal therapy? A six years, single center experience of 120

patients

Bapaye Amol, Aher Advay, Gadhikar Harshal, Shimpi Lalit

Department of Digestive Diseases & Endoscopy, Deenanath Mangeshkar Hospital &

Research Center, Pune, India

Objectives:

To analyze the results of 120 patients undergoing endoscopic pseudocyst

drainage over a 6 year period (2005-10).

Patients and methods:

Retrospective study. From 2005 to 2010, 120 patients underwent endoscopic

pseudocyst drainage under EUS guidance. Pseudocysts after acute pancreatitis (AP)

constituted 83 (69%), whereas the others 37 (31%) had associated chronic

pancreatitis (CP). After preop abdominal USG and CT scan, EUS guided transmural

drainage with / without balloon dilation of tract or ERCP transpapillary drainage was

performed. Necrosectomy was performed for cysts with solid debris within. A follow up

abdominal USG was performed at 1, 2 and 6 weeks. ERP was performed after 1 -2

weeks. When ductal abnormality was seen, pancreatic stent was placed for 3 – 6

weeks.

Results:

Cyst drainage was successful in 116/120 patients (96.6%). Cyst fluid was turbid in all

83 post AP patients (50, 61% had additional solid debris within cyst), and was clear in

37 patients with CP cysts. Four patients (3.4%) from post AP group had significant

solid debris and were excluded. All other 79 patients with post AP pseudocysts

underwent EUS guided drainage with balloon dilation of tract. Necrosectomy was

performed in 24/79 patients (30%). A median 2 (1-4) sessions were performed.

Subsequent ERP was done in 42 patients (53%). Ductal abnormalities (leak, stricture

or disconnection) were seen in 34/42 patients (81%). Stents were placed in 29/42

(69%) patients. In the CP group, 30/37 patients (81%) underwent EUS guided stent

placement without dilation of tract. One patient (3%) underwent tract dilation as fluid

was turbid. Four patients (11%) underwent EUS guided cyst aspiration followed by

ERP and pancreatic endotherapy. ERP was done in 28/37 (76%) patients. Two

patients underwent transpapillary drainage of cyst. Pancreatic Endotherapy (ESWL for

calculi, stent for stricture) was performed in 23/28 (82%) patients. Remaining 5

patients had ductal disconnection on ERP and could not be offered endotherapy.

Complications were seen in 33/116 (28.4%) patients. Surgical intervention was

needed in 21/120 (17.5%) patients. In the AP group (n=83), post procedure infection

in 18 (21.6%), hemorrhage in 4 (4.8%), residual intra abdominal fluid collections in 6

(7.2%) and death in 4 (4.8%) patients was seen. Cyst recurred in 5/37 (13.5%)

patients in the CP group, 4 treated by repeat endotherapy, one by surgery.

Conclusions:

Turbid fluid and solid debris needing tract dilation and necrosectomy is

frequently seen in cysts after AP. Duct abnormalities or leaks are common in both

groups and should be treated. A combination of cyst drainage and duct

decompression offers an optimum endoscopic approach to management of

pseudocysts.

Abstract presented as poster at Digestive Disease Week 2011, Chicago.

Endoscopic Stapling System for Trans Oral Treatment of GERD – Three Years

Follow Up

Aviel Roy-Shapira, Amol Bapaye

Objectives / Introduction:

Long Term Efficacy of an endoscopic stapling system for trans oral treatment of

GERD. Between May and October 2007, an IRB approved, pilot study of a new

endoscopic stapling device for the treatment of GERD was conducted on 13

subjects in Pune, India. Subjects with history of PPI use > 2 yr for GERD and no co-

morbidity were included. The device is a modified Gastroscope, which includes a

surgical stapler, that fires a staggered quintuplet of standard titanium B shaped 4.8

mm staples, and an ultrasonic range finder. All procedures were done under general

anesthesia by a single operator. Either 2 or 3 staple quintuplets were used to staple

the fundus to the esophagus, creating a 90-180 degree anterior fundoplication over

the distal 2-3 cm of the esophagus. This is a report of the results of a three year

follow up on this group of subjects.

Methods:

The original Informed consent specified that the subjects may be contacted annually

for 5 years following the study. Accordingly subjects were contacted for a telephone

interview during the first week of October 2010. The following data were collected:

Velanovich GERD-HRQL scores, PPI use, symptoms,

satisfaction with the procedure, and willingness to repeat the procedure again.

Results:

11 of the 13 subjects could be reached by phone. GERD-HRQL scores were less

than 9 or less in 10 subjects and 15 in one subject. The latter subject improved his

score from 29 to 15, in all others score improved by more than 50 %. All subjects

would have agreed to do the procedure again. Mean satisfaction score was 7.7 (6-

10) on a scale of 1 -10. There was no dysphagia. Three subjects resumed PPI

intake, (compared to 2 at the 2 yr follow up) 3 subjects require PPI at a reduced

dose 1 subjects takes PPI only after a large meal and 4 subjects remained

completely off PPI.

Conclusion:

At 3 years, the procedure remained effective in improving the quality of life in

moderate to severe GERD without causing dysphagia. PPI use was eliminated or

reduced in 73% of subjects. All subjects remain satisfied with the procedure and

would do it all over again. Further studies are necessary to validate these data and

determine optimal staple placement.

Abstract presented as poster during Digestive Disease Week 2011, Chicago

(Poster no. Su1620)

Abstracts

Esu-guided Therapy For Pancreatic Pseudocysts And Pancreatic Necrosis: An Experience

Of 19 Cases.

Bapaye, Deenanath Mangeshkar Hosppital, Department of Digestive Diseases & &

Endoscopy, Pune, India.

Introduction:EUS-guided pseudocyst drainage is a promising but evolving technique. Major

concerns are diameter of the cystogastrostomy and adequacy of the drainage procedure to

remove solid debris within the cyst cavity. We present our experience in 19 patients with

pancreatic pseudocysts or pancreatic necrosis wherein EUS guided therapy was used.

Methods:From July 2004 to January 2005, 19 patients with pancreatic pseudocysts were

subjected to EUSguided drainage. Seventeen patients had cysts following acute pancreatitis

while 2 after chronic pancreatitis (CP). Eight patients had simple cysts (clear contents) where as

11 had complicated cysts (multiloculated, thick fluid, necrotic debris in floor). Seven patients (all

complicated cysts) had recurrent cysts (surgical cystogastrostomy - 2, ERP + transpapillary

drainage – 2, repeated USG guided aspiration -2, EUS+ transgastric stenting – 1). Associated

sepsis was seen in 7 patients.

All patients underwent diagnostic EUS using a convex linear array echoendoscope followed by

drainage of the collection in the same sitting. Five patients with small cysts (volume <50 mL)

required only aspiration of cyst using a 19 or 22G FNA needle. EUS guided needleknife puncture

followed by guidewire placement into the cyst cavity was performed in 13 patients. In one patient

with a thick cyst wall, puncture was done by a 19G FNA needle followed by guidewire placement

through the needle. Dilatation of the tract up to 18 mm was then performed using an esophageal

dilator balloon over the guidewire. In patients with clear cyst contents, a Fr. Double pigtail stent

was placed across the fistula into the cavity. In patients with complicated cysts, agastroscope was

passedtransgastrically into the cyst cavity (Cystendoscopy). Using a polypectomy snare, septae

were broken, loose necrotic debris was removed from the cavity by cold snaring technique

(Endoscopic necrosectomy). A 7 Fr. Stent and a 7 Fr. Nasocystic catheter were placed in the

cavity and sterile saline irrigation was performed. Procedure was repeated every 3 days until the

wall looked healthy, USG/CT scan showed no residual

necrosis/collection or cyst cavity had collapsed. Additional ERP was performed in 7 patients

where ductal disruption was suspected (rapid refilling of the cyst, recurrent cysts).

Results:Ductal disruption was seen in 2, unsuspected early CP in 4, classical CP in the patient.

Appropriate endotherapy was performed. Follow up USG was performed at 2 weeks and later as

required. Stents were removed at 8 weeks. USG was repeated at 12 weeks after stent

removal.EUS –guided drainage was achieved in all 19 patients. Complete regression was seen in

8 patients (simple cysts) at 2 weeks, and in 17 and 8 weeks. Therapy failed in one patient who

required surgical

necrosectomy. Complications occurred in two patients (bleeding – 1, death – 1). Bleeding from the

fistula site in one patient after balloon dilatation was arrested using hemoclips. One patient died of

pulmonary embolism 2 weeks after drainage. No recurrence on USG at 12 weeks.

Conclusions:EUS guided therapy is a satisfactory method to treat pancreatic pseudocysts.

Necrotic debris or multiple loculations are not contraindications for endoscopic therapy. An

aggressive approach using balloon dilation and cystendoscopy is necessary to achieve results

comparable to surgery.

OUTCOME PREDICTORS OF HIGH FRQUENCY OSSILLATORY VENTILATION IN

ADULT ARDS

S.A.Jog1, T. Dravid1, P. Rajhans1, P.Akole1, B. Pawar1, B. Bhurke1,

A.Phadke2, R. Kulkarni2.

1 Deenanath Mangeshkar Hospital and research Centre, Intensive care

medicine, Pune, India.

2 Deenanath Mangeshkar Hospital and research Centre, Internal medicine,

Pune, India.

INTRODUCTION.

High frequency Oscillatory Ventilation (HFOV) is a promising rescue ventilator

modality in severe ARDS. Other modalities available for these patients are NO

inhalation, ECMO or Prone ventilation. Various outcome predictors of HFOV in

severe ARDS studied so far are APACHE II score, duration of conventional

ventilation before HFOV, pulmonary or extra pulmonary ARDS and improvement in

oxygenation after HFOV. The purpose of this study was to predict response to

HFOV either before or after its inhalation, so that likely non responder could be

switch to alternative rescue therapies early, to get their benefit. Hence we

retrospectively analysed the outcome predictors of HFOV in Adult ARDS patients.

METHODS

Setting 40 bedded multidisciplinary ICU of tertiary care Hospital in Pune India. HFOV

ventilation ARDS patients receiving Volume controlled Ventilation (VCV) as per the

ARDS protocol with PO2/FiO2 ≤ 150 in spite of PEEP ≥12 cm and FiO2 ≥ 0.7, were

considered for HFOV as rescue therapy. All patients were followed up till discharge

from the hospital (survivors) or death (non survivors).

RESULTS

Data of 39 patients were analysed. There were 12 survivors and 27 non survivors.

Mortality rate of 69.24% was attributable to “Rescue Use” of HFOV and 32 patients

having multiorgan failure Before HFOV. Table 1 and 2 shows parameters evaluated

as outcome predictors. Binary logistic Regression model was used to predict survival

as success full response to HFOV.

Statistical analysis 95% Confidence Interval for odds ratio. P value > 0.005 No

significant relationship of outcome predictors with the log of odds. *P value for

coefficient of “25% reduction in OI at 24 h” is 0.026<0.05, shows that there is

significant relationship of 25% reduction in OI with survival. Odds ratio is a ratio of

probability of survival to probability of death.

CONCLUSION

Reduction of Oxygenation Index by at least 25% within 24h after initiation of HFOV

emerged as a single, statistically significant outcome predictor which could predict

successful response to HFOV in Adult ARDS. Patients in whom this is not achieved

may be switched to alternative rescue therapies.

Abstracts

To study the awareness of Eye Donation and the knowledge applicability

gap in various groups of population

Dr. Nirmala Sarpotdar, Dr. Madhav Bhat., Mrs. Milan Patwardhan.

Introduction

Corneal diseases constitute a significant cause of visual impairment & blindness

in developing countries like India.

Objective

To study the awareness, knowledge and practice for Eye Donation in various

groups viz. Donor’s relatives, Prospective donors, Doctors, Relatives of Blind

person and General Population.

Methodology

Sample was collected from Deenanath Mangeshakar Hospital OPDs & vicinity of

Pune. Personal Data Sheet and a Questionnaire was filled in by the sample

(adults only). This questionnaire included the questions that could throw light on

the awareness, knowledge of eye donation of the individual who filled in the form.

Awareness score was calculated on the basis of three common questions.

Awareness score range was 0 to 4. Awareness score greater than 1 was

considered as cut off point for awareness and no awareness. Means, Standard

Deviations & Z values were calculated. Various groups were compared.

Results

General Population (11.13%) and Blinds’ Relatives (57.89%) groups have people

with ‘lack of awareness’ while in remaining three groups there is 100% awareness

about eye donation. Medical Professionals have highest Awareness and Blinds’

relatives have lowest awareness about eye donation. Donor’s relatives,

Prospective donors and General Population fall in between. The Z values of

successive groups show that the groups have significant difference in their

awareness score.

Suggestions

To create awareness among the Younger Population (next to kin).

Special campaign should be conducted for Medical Professionals / Para medicals

/ Priests (conducting the last rituals) can be more instrumental for the motivation

of relatives to donate eyes after the death of the patient.

Simulation of a colorectal polypoid lesion- a pilot porcine model

Doron Kopelman, MD, Amir Szold, MD, Yael Kopelman, MD, Alexander Geller,

MD, Shlomo Lelcuk, Amol Bapaye, Peter D. Siersema, Afula, Haifa, Tel Aviv,

Hadera, Petah Tiqva, Israel, Pune, India, Utrecht, The Netherlands

BACKGROUND:

Large sessile polyps almost always contain villous tissue with appreciable

premalignant potential and tend to recur locally after colonoscopic resection.

Developing new endoscopic techniques for the removal of polyps requires a large

animal model of colorectal polypoid lesions. So far, no appropriate large animal

model of a colorectal or other GI polyp has been described in the English literature.

OBJECTIVE:

Our purpose was to develop a large animal model simulating large, perfused and

viable, sessile colorectal polypoidal lesions, with distinct easily detectable histologic

features.

SETTING: An animal laboratory.

INTERVENTIONS:

Two simulated rectal polyps, using 2 different techniques, were created in

each of 10 animals. The polyps were simulated by ovarian tissue that was introduced

either intraluminally through the rectal wall or into a dissected submucosal space in

the rectal wall. In 2 animals the created polyps were endoscopically resected.

RESULTS:

All submucosal lesions were sessile-like polypoid lesions because the base of the

polyp was the widest diameter of the lesion. All transmural polypoid lesions had short

and thick pedicles. Resection by snaring and cutting was demonstrated to be

feasible.

The mean measurements of the submucosal-simulated

polyps were as follow: 1.74 cm (+/-0.32) * 2.07 cm (+/-0.42) * 1.51 cm (+/-0.27). The

mean measurements of the transmural-simulated polyps were significantly larger:

2.55 cm (+/-0.52) * 3.57 cm (+/-1.1) * 2.7 cm (+/-0.64).

LIMITATION:

This model does not simulate a real intestinal neoplasia.

CONCLUSION:

Either method, the submucosal or the transmural, could be helpful in the research

and development efforts of surgical and endoscopic treatments of intestinal

polyps.

Citation: [Gastrointest Endosc 2008; 67 (7): 1159-67]

Drotrecogin Alpha –Cutting Cost, Not Corners!

S. Jog 1 , T. Dravid1 , P. Phadke2 , R. Kulkarni2 , N. Bapat2, P. Akole1 , B. Pawar 1,2 Deenanath Mangeshkar Hospital and Research Centre , Intensive Care Medicine ,

Pune , India

INTRODUCTION

Drotrecogin alpha (DA) is an effective treatment in sepsis induced Multi Organ

Dysfunction Syndrome (MODS) especially in the presence of Septic Shock (SS)

Optimum duration of treatment of DA is 96 h infusion. Cost of DA infusion for 96 h is

average INR 480,000 (Euro7680) in India , whereas the average cost of 8 days of

ICU treatment of a patient with sepsis with MODS, including bed charges , organ

support therapies, drugs , laboratory investigations and consultation fees is

approximately INR 120,000 (Euro 1920). Thus the cost of 24 h infusion of DA is

approximately equal to 8 day cost of standard ICU care. It is unclear whether

stopping DA before 96 h , in patients in whom SS resolves before 96h ultimately

affects outcome. This is more relevant in developing countries like India where cost

of 96 h of infusion of DA is beyond the reach of majority of patients

eligible for DA . We performed a prospective study to evaluate this concept.

METHODS

During the period of June 2006 to December 2008 patients with severe sepsis

having ≥ 2 organ Dysfunction (O.D.) were offered the option of DA as an adjunct

therapy for those who opted for it , DA infusion was initiated within 24 h of onset of

SS DA infusion was stopped before completion of 96 h. Other ICU care was provided

as per contemporary standard of care . All these patients were hemodynamically

monitored in the ICU after stopping the Infusion.

Results

172 patients with severe sepsis having ≥ 2 Organ Dysfunction , were offered the

option of DA. 18 patients opted for it . In 13 out of these 18 patients DA infusion

could be stopped before 96 h assuming complete reversal of septic shock. Their data

were analysed in this study . Average APACHE II and SAPS II scores were 22.23 ±

3.87 and 53.92 ± 14.45 respectively 11 out of 13 patients were discharged home

after complete recovery. Shock did not reappear in the subsequent 72 h in any of

the 13 patients . Two patients developed new episode of ventilatory Associated

Pneumonia on day 4 and 10 respectively after stopping the infusion of DA and could

not be salvaged.

CONCLUSION

DA infusion can be safely stopped before completion of 96 h in patients who show

rapid reversal of SS . This is associated with significant cost saving without

compromising the outcome or quality of care.

Abstracts

Deenanath Mangeshkar Hiospital & Research Centre

15

Macro and Microcirculation: 0098-0111

0098 STROKE VOLUME VARIATION – GUIDE TO FLUID THERAPY IN SEPTIC

SHOCK WITH ARDS

S.Jog1, T.Dravid1, P.Rajhans1, B.Bhurke1, S.Mangrulkar2, V.Amritkar2, T.Vora1, S.Patil1 1Deenanath Mangeshkar Hospital and Research Centre, Intensive Care Medicine,

Pune, India 2Deenanath Mangeshkar Hospital and Research Centre, Internal Medicine, Pune,

India

INTRODUCTION.

Use of stroke volume variation (SVV) to guide fluid therapy in preload responsive state

has been studied well in patients undergoing cardiac or neurosurgery during

anesthesia. Use of this dynamic monitoring variable has not been studied much in

septic shock. We undertook this prospective study to evaluate utility of SVV to optimize

preload in patients with septic shock and ARDS.

METHODS.

Setting. 40 bedded medical surgical ICU of a 350 bedded tertiary care centre in Pune,

India.Inclusion Criteria:

1.Patients with ARDS (PO2/FiO2 200),

2.Septic shock of duration 24 h needing vasopressors; either Dopamine >= 10µg/(kg

min) or norepinephrine 0.1 µg/(kg min)to maintain mean arterial pressure (MAP)

above 65 mm of Hg.3.CVP attained >15 mm prior to enrollement4.SVV 13%

Exclusin Criteria (a) Atrial or ventricular arrhythmias b.Non requirement of controlled

invasive mechanical ventilation c.Acute coronary syndromed. Need for any form of

renal replacement therapy e. Prone position ventilation or extra corporeal life support

for ARDS.SVV readings were taken every 3 h with Flotrac – Vigileo system after

Confirming abolishment of spontaneous breaths by sedation or paralysis and

increasing tidal volume transiently to 8ml/kg. Fluid boluses were given to keep

SVV<13% for 24h after enrollment. Attempts were made to reduce vasopressor doses

keeping MAP 70mmHg.

RESULTS.

20 patients with average age 57.9 ± 16.55 years and APACHE II score

22.2 ± 5.14 were studied. Each patient received an average 6.22 ± 2.54 fluids in 24 h

after enrollment to keep SVV below 13%. SVV at 24 h after was 10.1 ± 6.13%.

Improvement in microcirculation was evident as Plasma lactate reduced from 5.43 ±

3.64 (at o h) to 3.09 ± 2.78 mmol/l (at 24 h ) There was no worsening in pulmonary

edema as PO2/FiO2 increased from 165.3 ± 106.1 (at o h) to 224 ± 100.66 (at 24 h).

Only 6 out of 20 patients needed Renal Replacement Therapy. In 13 patients,

vasopressors could be stopped completely in 49.7 ± 19.02 h. 12 of them survived till

discharge from the ICU and 1 died of ARDS. In 7 patients, vasopressors could not be

weaned off completely and all of them succumbed. Overall survival rate was 60%.

CONCLUSION.

SSV guided fluid therapy is a promising modality for pre load optimiozation in

mechanically ventilated patients with septic shock and ARDS.

‘A study of bacterial monitoring of air in the laminar

air flow operation theatre using an air sampling machine - its role in ccurrence

of or prevention of infection in prosthetic replacement arthroplasties’.

Principle investigators:- 1) Dr. Mahesh Kulkarni (Consultant surgeon, orthopedics,

DMH) 2) Dr. Sampada Patwardhan (Consultant Microbiologist, DMH)

Co investigators:- Dr. Hemant Wakankar (Consultant Surgeon, orthopedics, DMH)

Research associate:-Dr. Sinu Bhaskaran

AIMS AND OBJECTIVES:-

Superficial and deep infections in prosthetic replacement

arthoplasties are a result of microorganisms present in the operation theatre air and

infection rates correlate with the no. of bacteria in the vicinity of the operative wound.

As few as 10 bacteria (colony forming units i.e. CFU) are sufficient to cause deep

infections in implanted joints. Our study was planned with an intention of carrying out

a proper scientific investigation into the effect of the bacterial load in the

perioperative field on the occurrence of infections in implanted prosthetic joints.

Monitoring the bacterial counts indicates the effectiveness of the laminar air flow

HEPA ventilation system and use of total body occlusive suits in minimizing the in

bacterial counts in the perioperative field.

MATERIALS AND METHODOLOGY:-

100 total Hip/knee replacement surgeries carried in O.T. NO- 6 will be included in the

study. Samples of air are taken from the perioperative field i.e. within the laminar air

flow zone at three stages during the surgery a) before the incision is taken b) during

the operative procedure c) immediately after final closure of the wound. 10,000 liters

of air is sampled onto blood agar petri plates at each stage using an air sampler.

(company HiMedia, Model La030) The blood agar petri plates are incubated for 24

hours at 370C and total no of CFU/m3 of air is calculated. The results are noted on

the procedure record form and reported as satisfactory / not satisfactory using 10

cfu/m3 as the acceptable safe limit. Follow up of the patients for surgical site

infection will be done for 1 year post op.

Abstracts

Publications Year 2010

• Abhay Rane, Anil Bradoo, Pradeep Rao, Subodh Shivde, Mostafa Elhilali, Maurice Anidjar, Kenneth Pace And John R. D A Honey , The Use Of A Novel Reverse

Thermosensitive Polymer To Prevent Ureteral Stone Retropulsion During Intracorporeal Lithotripsy: A Randomized, Controlled Tria ,The Journal Of Urology, vol.

183, 1417-1423, April 2010

• Subodh Shivde, Pankaj Joshi, Mahesh Mandolkar ,Testicular Filariasis masquerading as a testicular tumour – case report with review of literature ,The Internet

Journal of Surgery 2010 ,Volume 23, Number 1

• Subodh Shivde, Pankaj Joshi, Tushar.A.Dighe, Jaydeep Date, Unusual causes of obstruction to transplant ureter- a case report with review of literature of some

rare cause , Saudi Journal of Kidney Diseases and Transplantation , 2010, 21(2),

• J. Deuskar, P. Joshi, U. Adbe & A. Railkar : Signet Ring Cell Carcinoma Of The Ileum – A Case Report And Review Of Literature. The Internet Journal of Surgery.

2010 Volume 25 Number 1

• Bapaye, Aher , Bhide V2, Joshi V, A single center experience of EUS guided fine needle aspiration cytology (FNAC) in pancreatic mass lesions : Journal of

Gastroenterology & Hepatology 2010;25 (Suppl. 2):A151.

Year 2009

• Rajan Joshi, Farzana Shaikh, Sachin Gandhi, Pallavi Thekedar ,Endoscopic laser for severe laryngomalacia, Indian Pediatrics, Vol 46, No.8, Aug 2009, 717-19.

• V.H.Oswal, S.S.Gandhi Endoscopic laser management of bilateral abductor palsy, Indian Journal of Otolaryngology and Head and Neck Surgery, Vol 61 / Supplement

1 / 2009, 47-51.

• Rohit Phadtare, Rajan Joshi, Arti Rajhans, Sheela Patil, Sily Dominic, Uday Devaskar High flow nasal cannula oxygen (Vapotherm) in premature neonates with

respiratory distress syndrome: Is it better than the conventional nasal continuous positive airway pressure (NCPAP)?, Perinatology: Journal of perinatal and

neonatal care, Vol 11, No. 1, June 2009, 1-8

• Bhargav P., Joshi R., Patwardhan S., Nadar R., Tayade N ,Four years old with fever for 5 months. Case file of Deenanath Mangeshkar Hospital Pune., Pediatric

Infectious disease: Journal of the Indian academy of Pediatrics, Infectious disease chapter, Vol 1, No. 1, Jan-Mar 2009, 28-31

• Pallavi Bhargava, Brucellosis – An overview, Pediatric Infectious disease: Journal of the Indian academy of Pediatrics, Infectious disease chapter, Vol 1, No. 1, Jan-Mar

2009

• Subodh Shivde, Pankaj Joshi, Jaydeep Date, Sucheta Iyer, Ileocalicostomy with augmentation cystoplasty in ureteric stricture due to genitourinary

tuberculosis,Internet Journal of the British Association of Urological Surgeons, Sept 2009

• Subodh Shivde, Diabetic Cystopathy and Benign Prostatic Hyperplasia(BPH),Diabetes- Update,January 2009

• S. Jog ,T.Dravid, P.Rajhans , B. Bhurke , S. Mangrulkar, V. Amritkar , T.Vora , S.Patil , Stoke volume variation -Guide to Fluid Therapy IN Septic Shock with ARDS

,ESICM Annual Congress -Vienna Austria

• S. A. Jog, T. Dravid, P. Rajhans, P. Akole, B. Pawar, B. Bhurke, A. Phadake, R.Kulkarni, Outcome predictors of high frequency oscillatory ventilation in adult

ARDS, 28th IInternational Symposium on Intensive Care and Emergency Medicine (ISICEM), Brussels, Belgium

• Date J, Shivde S, Langer R, Joshi P ,Holmium laser enucleation of prostrate – our initial experience ,West zone urological conference, Khajuraho, India.

• S.Jog, T.David, P.Phadke, R.Kulkarni, N.Bapat, P.Akole, B.Pawar Drotrecogin Alpha – Cutting cost, Not corners! 22nd ESICM Annual congress – Vienna, Austria.

• J.Singh, S.Tapasvi, A.Babhulkar , Long head of biceps brachii tendon, biceps-labral complex and the biceps pulley: Evaluation with MRI and MR arthrogram of the

glenohumeral joint ,ECR 2009, European congress of radiology, march 6-10, Vienna, Austria.

• Date J, Shivde S, Langer R, Joshi P, Role of Percutaneous nephrostomy urine specimen culture in preventing urosepsis in PCNL ,National Urological society of

India, Indore, India.

Publications Year 2008

• Pankaj.M.Joshi, Subosh.R.Shivde, Tushar.A.Dighe ,Knotting of the guide wires: A rare complication during minimally invasive procedure on kidney –

lessons learnt , Journal of Minimum Access Surgery Vol 4(4), Oct-Dec 2008.

• S.Shivde, P.Joshi, R.Jamkhandikar , Extrusion of Double J stent: A rare complication,Urology: Official Journal of Societe Internationale D’Urologie,Vol 71, Issue

5, May 2008.

• Subodh Shivde, Pankaj Joshi, Vaibhav Gorde, Jitendra Deuskar, Dhananjay Kelkar ,Laparoscopic transperitoneal surgery for Adrenal cysts, The Internet Journal

of Surgery, Vol 17, No. 2, 2008.

• Subodh Shivde, P.Joshi, R.Jamkhandikar Extrusion of Double J stent: A rare complication ,Urology: Official Journal of Societe Internationale D’Urologie, Vol 71,

Issue 5, May 2008

• Pankaj.M.Joshi, Subosh.R.Shivde, Tushar.A.Dighe , Knotting of the guide wires: A rare complication during minimally invasive procedure on kidney –

lessons learnt , Journal of Minimum Access Surgery, Vol 4(4), Oct-Dec 2008,

• Subodh Shivde, Pankaj Joshi, Vaibhav Gorde, Jitendra Deuskar, Dhananjay Kelkar, Laparoscopic transperitoneal surgery for Adrenal cysts, The Internet Journal

of Surgery,Vol 17, No. 2, 2008Date J, Shivde S, Langer R, Joshi P Bipolar TURP – our experience ,West zone urological conference, Sholapur, India

• J.Singh, K.Godbole, V.M.Bhide Fetal MRI: Incremental value in fetal imaging and impact on decision making ECR 2008, European congress of radiology, march

7-11, Vienna,

• Date J, Shivde S, Dighe T, Joshi P, Fungal peritonitis following CAPD ,Conference of National Urological society of India, Chennai, India Jan 2008

Year 2007

• Rajan Joshi, Sheela. S. Patil, Sili Dominic, Usha pratap, Arti.P.Rajhans, Uday.Devaskar,Is inhaled nitric oxide therapy in neonates with primary pulmonary

hypertension in developing countries like India feasible?, Perinatology: Journal of perinatal and neonatal care ,Vol 9, Number 3, May-June 2007

• J.Singh, D.S.Kelkar, S.Pingley , Utility of Whole body MRI for metastases screening, ECR 2007, European congress of radiology, march 9-13, Vienna, Austria

• J.Singh, R.Kulkarni Imaging in tropical infections of the brain ECR 2007, European congress of radiology, march 9-13, Vienna, Austria FEB2007

Year 2006

• Joshita.Singh, Ashish.Babhulkar, Utility of MR arthrogram of the shoulder in evaluation of myotendinous pathologies, 11th Asian Oceanian Congress of

Radiology, Hongkong SAR, China AUG 2006

• Joshita.Singh, Dhananjay Kelkar Whole body MRI – An effective tool for metastatic screening ,11th Asian Oceanian Congress of Radiology, Hongkong SAR,

China, 2006

Awards and Patents

Name of the principal

investigator

Name of the award received Year of reception of award Title of the project

Ms. Namita Mahale

Dr. Sadanand Naik (PI)

Dr. Ashish Babhulkar

First prize in Biochemistry at research

student seminar

2011 Effect of milk/milk products

consumption on plasma holo-

transecobalamine and Vitamin B12

concentration

Dr. H.M.Wakankar Best paper Ranawat orthopaedic conf

(Kolkotta)

2010 Safety profile of single stage

bilateral TKRS (714 cases)

Dr. H.M.Wakankar Best paper (session) (MOACON – Nasik) 2010 Sequence of medial release in

varus knees (1994 TKRS)

Dr.H.M.Wakankar

Dr.M.M.Kulkarni

Best paper (session) (MOACON – Nasik) 2010 Efficacy of laminar airflow in

reducing air-borne bacterial count

Dr. H.M.Wakankar Poster award (MOACON – Nasik) 2010 Computer navigation in TKRS with

extra articular deformity

Dr. Vijayashri Bhide,

Dr. Koumudi Godbole

Dr. Savitri Nerune

First prize for paper presentation at

MOACON – Nasik

2009 Fetal pathology-clinico-pathological

correlation

Dr. H.M.Wakankar Best paper Ishks 2009(new Delhi) 2009 Complication rates in single stage

bilateral TKRS(664 cases)

Dr. Sameer Jog Best paper presentation 2008 Intermittent hemodialysis in septic

shock patients – cutting costs; not

corners

Dr. Sameer Jog Best paper presentation 2008 High frequency oscillatory

ventilation in ARDS – can we

predict success?

Dr. Arvind Bhave Patent under new IP laws,No+198510 2008 AB Needle for Vertebroplasty.

Achievements

Accreditation by Department of Scientific and Industrial Research

(DSIR): Accreditation was granted for two years in 2009. It has been

extended for three years in 2011.

Research department has appointment of three subcommittees for

scientific review of the research projects to assist Institutional

Ethics committee.

Full fledged intranet website for submission of all application forms

to get approval for research studies, answers for frequently asked

questions, guide to write research proposals, information on

functions and working of Institutional Ethics committee (IEC) and

sub committees.

Research department has now started ‘Promotion of Research’ by

assisting other departments at DMHRC in terms of designing

questionnaire, conducting the study, data collection, analysis,

interpretation, and basic help with writing manuscripts.

Zooming ahead

• Improve Quality of research studies

• Learn to write National and International research grant

proposals.

• Create research culture and awareness

• Research Collaboration with researchers from other

hospitals/Institutions

• Further impetus of Integrated Research: Research in more than

one pathy

• Accreditation from office of Human Research Protection (OHRP)

for IEC.

Acknowledgements

Contributions towards research

@ DMHRC:

Dr. S.Y. Paranjape,

Dr. Seeta Nair,

Dr. Sanjeev Mangrulkar,

Dr. Sameer Jog,

Dr. Subodh Shivde,

Dr Pallavi Bhargava,

Dr. Anantbhushan Ranade,

Mr. Vishwanath Gujar,

Mr. Vivek Kulkarni,

Dr. Atul Mulay,

Dr. Koumudi Godbole,

Dr. Vaishali Deshmukh,

Dr. Parag Rote

Dr. Sanjay Phadke

Our Collaborators:

Dr. Nene supports Integrated Research.

Dr. Gokhale had supported Neem project.

JPSS: All psycho-social projects.

M. L.Dhavle Homeopathic Institute:

Promotion of homeopathic research.