1
Preoperative Carbohydrate Loading in Enhanced Recovery After Surgery Pathways is Safe in Patients with Type II Diabetes Stephanie D. Talutis MD, MPH 1 , Su Yeon Lee BS 1 , Daniel Cheng MD 2 , Pamela Rosenkranz RN, BSN, MEd 1 , Sarah M. Alexanian MD 1 , David McAneny MD, FACS 1 1 Department of Surgery, Boston University School of Medicine, Boston, MA, 2 Department of Surgery, University of Nevada, Las Vegas, NV AIM The objective of this study is to determine the safety of preoperative carbohydrate loading in patients with DM II Demonstrate no signi<icant difference in blood glucose levels, insulin requirements, inpatient endocrine consultations, hypoglycemic episodes, and postoperative complications in patients with DMII during the <irst year of ERAS program at BMC METHODS IRB-approved retrospective chart review Analyzed patients during the <irst year of ERAS (10/1/15 9/30/16) Exclusion criteria Diet-controlled DMII Those without documented consumption of CHO Type I Diabetes Additional group consisted of historical patients with DMII Statistics: Demographic and perioperative variables were compared among the three groups using ANOVA Differences between groups of patients with DMII were evaluated using Chi square test for categorical variables and Kruskal Wallis test for continuous variables Signi<icance de<ined as p <0.05 RESULTS CONCLUSIONS ERAS patients with DMII safely tolerate CHO as part of an ERAS pathway without an increase in insulin requirements or increase in complications NEXT STEPS There is no consensus within the ERAS literature with regard to the type or quantity of preoperative CHO beverages. Future studies can investigate speci<ic CHO composition for patients with and without DMII to assess any impact on perioperative glucose levels, insulin requirements, and other outcomes. The ERAS program at Boston Medical Center continues to includ carbohydrate loading patients with DMII BACKGROUND Enhanced Recovery After Surgery (ERAS) pathways involve evidence based protocols to minimize the stress response to surgery 1 ERAS efforts include education, reduced IV <luids, and decreased narcotics 1 In many ERAS models, patients drink a preoperative carbohydrate load (CHO) 2 hours prior to surgery, which improves nitrogen balance and decreases nausea and ileus 1-3 There are limited data regarding the safety of carbohydrate loading in patients with Type II Diabetes (DMII) 3 Since the inception of the ERAS program at Boston Medical Center, we have intentionally included carbohydrate loading patients with DMII RESULTS Table 1: Demographics ERAS Patients ERAS Patients Historical Patients without DMII with DMII with DMII p Value (n = 275) (n = 80) (n = 89) Median age in years (range) 43 (21-89) 48 (20-86) 51 (25-93) 1.000 Female % 74.9% (206/275) 78.8% (63/80) 74.2% (66/89) 0.743 Median BMI (range) 39.5 (16.7 - 81.4) 38.6 (19.8-69.5) 40.5 (20.7-59.3) 0.367 Operative Duration, hours 3.02 (1.50-11.10) 3.18 (1.67-10.80) 2.7 (1.70-11.60) 0.085 (range) Specialty % 0.200 Bariatric 62.9% (173/275) 71.3% (57/80) 67.4% (60/89) Colorectal 25.8% (71/275) 13.8% (11/80) 23.6% (21/89) Surgical Oncology 11.3% (31/275) 15% (12/80) 9.0% (8/89) Laparoscopic % 83.6% (230/275) 90% (72/80) 93.3% (83/89) 0.078 ASA 1.000 1 0.4% (1/275) 0% (0/80) 0% (0/89) 2 51.6% (142/275) 22.5% (18/80) 38.2% (34/89) 3 47.6% (131/275) 67.3% (61/80) 60.7% (54/89) 4 0.4% (1/275) 1.3% (1/80) 1.1% (1/89) Table 2: Perioperative Diabetic Variables ERAS Patients Historical Patients with DMII with DMII p Value (n = 80) (n = 89) Hemoglobin A1C median (range) 7 (5 - 12.5) 7.4 (5.5 - 12.6) 0.432 Home Diabetes Medications 1.000 Oral Agent 90% (72/80) 92.1% (82/89) Insulin 28.8% (23/80) 23.6% (21/89) Number of Agents 0.698 1 57.8% (47/80) 66.3% (59/89) 2 25% (20/80) 22.5% (20/89) 3 7.5% (6/80) 9.0% (8/89) 4 3.8% (3/80) 2.2% (2/89) Home Insulin Dosing, median units (range) 36 (6-178) 39 (6-200) 0.760 Median Glucose (range) Preoperative (Holding Area) 142 (66 - 392) 129.5 (82 - 316) 0.017* Operating Room 158 (95 - 286) 174.8 (100 - 279.5) 0.913 1st Postoperative 159 (102-309) 173 (96-295) 0.231 Daily Median Postoperative Day 0 184.5 (106 - 320) 175 (86 - 350) 0.145 Postoperative Day 1 152 (84-323) 137.5 (86 - 279) 0.004* Postoperative Day 2 135.3 (82 - 223) 131 (82-240) 0.446 Postoperative Day 3 134 (67 - 207) 134.8 (78 - 220.5) 0.634 Postoperative Day 4 135.5 (81 - 232) 138.3 (89.5-201.5) 0.787 Postoperative Day 5 135 (85-171.5) 146 (79 -220) 0.438 Intraoperative Insulin Infusion 11.3% (9/80) 14.6% (13/89) 0.648 Insulin, median units (range) OR 0 (0 - 16.5) 0 (0 - 19.2) 0.625 Postoperative Day 0 2 (0 - 62) 2 (0 - 75.83) 0.669 Postoperative Day 1 4 (0 - 75) 0 (0-79) 0.094 Postoperative Day 2 0 (0-53) 0 (0-41) 0.187 Postoperative Day 3 4 (0-47) 0 (0-50) 0.995 Postoperative Day 4 4 (0-54) 2 (0-45) 0.767 Postoperative Day 5 2 (0-37) 0 (0-55) 0.765 Table 3: Outcomes ERAS Patients ERAS Patients Historical Patients without DMII with DMII with DMII p Value (n = 275) (n = 80) (n = 89) % Hypoglycemia - 7.5% (6/80) 5.6% (5/89) 0.758 % Inpatient Endocrine Consultation - 41.3% (33/80) 37.1% (33/89) 0.637 Clavien-Dindo Classification 0.651 No Complication 78.9% (217/275) 80% (64/80) 73.0% (65/89) Grade I 7.6% (21/275) 12.5% (10/80) 14.6% (13/89) Grade II 8.7% (24/275) 5% (4/80) 7.9% (7/89) Grade IIIa 2.5% (7/275) 2.5% (2/80) 2.2% (2/89) Grade IIIb 2.2% (6/275) 0% (0/80) 2.2% (2/89) Antiemetic Doses, median (range) 0 (0-9) 0 (0-5) 1 (0-13) 1.000 Length of Stay, median (range) 2 (0-37) 2 (2-33) 2 (1-14) 0.383 Table 4: Binary Logistic Regression Risk of Any Complication Odds Ratio 95% Confidence Interval p Value Lower Upper Hemoglobin A1C 0.482 0.197 1.179 0.11 Number of Hypoglycemic Medications 1.316 0.489 3.537 0.587 Preoperative Insulin Dosing 0.983 9.58 1.009 0.192 Preoperative Glucose Measurement 1.008 0.993 1.024 1.008 References 1.Nygren J, Soop M, Thorell A, Efendic S, Nair KS, Ljungqvist O. Preoperative oral carbohydrate administration reduces postoperative insulin resistance. Clin Nut, 1998;17(2):65- 71. 2.Blixt C, Ahlstedt C, Ljungqvist O, Isaksson B, Kalman S, Rooyackers O. The effect of perioperative glucose control on postoperative insulin resistance. Clinl Nutr, 2012;31(5):676. 3.Gustafsson UO, Nygren J, Thorell A, et al. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesth Scand. 2008; 52(7):946-951.

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PreoperativeCarbohydrateLoadinginEnhancedRecoveryAfterSurgeryPathwaysisSafeinPatientswithTypeIIDiabetes

StephanieD.TalutisMD,MPH1,SuYeonLeeBS1,DanielChengMD2,PamelaRosenkranzRN,BSN,MEd1,SarahM.AlexanianMD1,DavidMcAnenyMD,FACS1

1DepartmentofSurgery,BostonUniversitySchoolofMedicine,Boston,MA,2DepartmentofSurgery,UniversityofNevada,LasVegas,NV

AIM • TheobjectiveofthisstudyistodeterminethesafetyofpreoperativecarbohydrateloadinginpatientswithDMII

• Demonstratenosigni<icantdifferenceinbloodglucoselevels,insulinrequirements,inpatientendocrineconsultations,hypoglycemicepisodes,andpostoperativecomplicationsinpatientswithDMIIduringthe<irstyearofERASprogramatBMC

METHODS

• IRB-approvedretrospectivechartreview

• Analyzedpatientsduringthe<irstyearofERAS(10/1/15–9/30/16)

• Exclusioncriteria•  Diet-controlledDMII•  ThosewithoutdocumentedconsumptionofCHO•  TypeIDiabetes

• AdditionalgroupconsistedofhistoricalpatientswithDMII

• Statistics:•  Demographic and perioperative variables were

comparedamongthethreegroupsusingANOVA•  Differences between groups of patients with DMII

wereevaluatedusingChisquaretestforcategoricalvariables and Kruskal Wallis test for continuousvariables

•  Signi<icancede<inedasp<0.05

RESULTS

CONCLUSIONS ERASpatientswithDMIIsafelytolerateCHOaspartofanERASpathwaywithoutanincreaseininsulinrequirementsorincreaseincomplications

NEXT STEPS •  ThereisnoconsensuswithintheERASliteraturewithregardtothetypeorquantityofpreoperativeCHObeverages.

•  Futurestudiescaninvestigatespeci<icCHOcompositionforpatientswithandwithoutDMIItoassessanyimpactonperioperativeglucoselevels,insulinrequirements,andotheroutcomes.

•  TheERASprogramatBostonMedicalCentercontinuestoincludcarbohydrateloadingpatientswithDMII

BACKGROUND• Enhanced Recovery After Surgery (ERAS) pathways involve evidencebasedprotocolstominimizethestressresponsetosurgery1

• ERAS efforts include education, reduced IV <luids, and decreasednarcotics1

• InmanyERASmodels,patientsdrinkapreoperativecarbohydrateload(CHO)2 hours prior to surgery,which improvesnitrogenbalance anddecreasesnauseaandileus1-3

• TherearelimiteddataregardingthesafetyofcarbohydrateloadinginpatientswithTypeIIDiabetes(DMII)3

• SincetheinceptionoftheERASprogramatBostonMedicalCenter,wehaveintentionallyincludedcarbohydrateloadingpatientswithDMII

RESULTS

Table1:DemographicsTable1:Demographics

ERASPatients ERASPatients HistoricalPatientswithoutDMII withDMII withDMII pValue(n=275) (n=80) (n=89)

Medianageinyears(range) 43(21-89) 48(20-86) 51(25-93) 1.000Female% 74.9%(206/275) 78.8%(63/80) 74.2%(66/89) 0.743MedianBMI(range) 39.5(16.7-81.4) 38.6(19.8-69.5) 40.5(20.7-59.3) 0.367OperativeDuration,hours 3.02(1.50-11.10) 3.18(1.67-10.80) 2.7(1.70-11.60) 0.085(range)Specialty% 0.200Bariatric 62.9%(173/275) 71.3%(57/80) 67.4%(60/89)Colorectal 25.8%(71/275) 13.8%(11/80) 23.6%(21/89)SurgicalOncology 11.3%(31/275) 15%(12/80) 9.0%(8/89)

Laparoscopic% 83.6%(230/275) 90%(72/80) 93.3%(83/89) 0.078ASA 1.0001 0.4%(1/275) 0%(0/80) 0%(0/89)2 51.6%(142/275) 22.5%(18/80) 38.2%(34/89)3 47.6%(131/275) 67.3%(61/80) 60.7%(54/89)4 0.4%(1/275) 1.3%(1/80) 1.1%(1/89)

Table2:PerioperativeDiabeticVariablesTableII:PerioperativeDiabeticVariables

ERASPatients HistoricalPatients

withDMII withDMII pValue

(n=80) (n=89)

HemoglobinA1Cmedian(range) 7(5-12.5) 7.4(5.5-12.6) 0.432

HomeDiabetesMedications 1.000

OralAgent 90%(72/80) 92.1%(82/89)

Insulin 28.8%(23/80) 23.6%(21/89)

NumberofAgents 0.698

1 57.8%(47/80) 66.3%(59/89)

2 25%(20/80) 22.5%(20/89)

3 7.5%(6/80) 9.0%(8/89)

4 3.8%(3/80) 2.2%(2/89)

HomeInsulinDosing,medianunits(range) 36(6-178) 39(6-200) 0.760

MedianGlucose(range)

Preoperative(HoldingArea) 142(66-392) 129.5(82-316) 0.017*

OperatingRoom 158(95-286) 174.8(100-279.5) 0.913

1stPostoperative 159(102-309) 173(96-295) 0.231

DailyMedian

PostoperativeDay0 184.5(106-320) 175(86-350) 0.145

PostoperativeDay1 152(84-323) 137.5(86-279) 0.004*

PostoperativeDay2 135.3(82-223) 131(82-240) 0.446

PostoperativeDay3 134(67-207) 134.8(78-220.5) 0.634

PostoperativeDay4 135.5(81-232) 138.3(89.5-201.5) 0.787

PostoperativeDay5 135(85-171.5) 146(79-220) 0.438

IntraoperativeInsulinInfusion 11.3%(9/80) 14.6%(13/89) 0.648

Insulin,medianunits(range)

OR 0(0-16.5) 0(0-19.2) 0.625

PostoperativeDay0 2(0-62) 2(0-75.83) 0.669

PostoperativeDay1 4(0-75) 0(0-79) 0.094

PostoperativeDay2 0(0-53) 0(0-41) 0.187

PostoperativeDay3 4(0-47) 0(0-50) 0.995

PostoperativeDay4 4(0-54) 2(0-45) 0.767

PostoperativeDay5 2(0-37) 0(0-55) 0.765

Table3:OutcomesTable3-Outcomes

ERASPatients ERASPatients HistoricalPatients

withoutDMII withDMII withDMII pValue

(n=275) (n=80) (n=89)

%Hypoglycemia - 7.5%(6/80) 5.6%(5/89) 0.758

%InpatientEndocrineConsultation - 41.3%(33/80) 37.1%(33/89) 0.637

Clavien-DindoClassification 0.651

NoComplication 78.9%(217/275) 80%(64/80) 73.0%(65/89)

GradeI 7.6%(21/275) 12.5%(10/80) 14.6%(13/89)

GradeII 8.7%(24/275) 5%(4/80) 7.9%(7/89)

GradeIIIa 2.5%(7/275) 2.5%(2/80) 2.2%(2/89)

GradeIIIb 2.2%(6/275) 0%(0/80) 2.2%(2/89)

AntiemeticDoses,median(range) 0(0-9) 0(0-5) 1(0-13) 1.000

LengthofStay,median(range) 2(0-37) 2(2-33) 2(1-14) 0.383

Table4:BinaryLogisticRegression–RiskofAnyComplication

OddsRatio 95%ConfidenceInterval pValueLower Upper

HemoglobinA1C 0.482 0.197 1.179 0.11NumberofHypoglycemicMedications 1.316 0.489 3.537 0.587PreoperativeInsulinDosing 0.983 9.58 1.009 0.192PreoperativeGlucoseMeasurement 1.008 0.993 1.024 1.008

References 1. NygrenJ,SoopM,ThorellA,EfendicS,NairKS,LjungqvistO.Preoperativeoralcarbohydrateadministrationreducespostoperativeinsulinresistance.ClinNut,1998;17(2):65-71.2. BlixtC,AhlstedtC,LjungqvistO,IsakssonB,KalmanS,RooyackersO.Theeffectofperioperativeglucosecontrolonpostoperativeinsulinresistance.ClinlNutr,2012;31(5):676.3. GustafssonUO,NygrenJ,ThorellA,etal.Pre-operativecarbohydrateloadingmaybeusedintype2diabetespatients.ActaAnaesthScand.2008;52(7):946-951.