Vasopressin CPR Trial Community Consultation

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Text of Vasopressin CPR Trial Community Consultation

  • 1. VasopressinCPR Trial Community Consultation Childrens Medical Center and The University of Texas Southwestern Medical Center

2. Principal Investigator

  • Tia Tortoriello Raymond, M.D.
  • University of Texas Southwestern Medical Center
  • Childrens Medical Center Dallas
  • Department of Pediatrics
  • 1935 Medical District Drive
  • Dallas, TX 75235
  • (214) 456-2281

3. Sub-investigator

  • Timothy G. Carroll, M.D.
  • University of Texas Southwestern Medical Center
  • Childrens Medical Center Dallas
  • Department of Pediatrics
  • 1935 Medical District Drive
  • Dallas, TX 75235
  • (214) 456-7614

4. Who is sponsoring the study and how many patients will be enrolled?

  • The study is funded by the primary investigator and is not sponsored by industry
  • Approximately 130 subjects will be enrolled in this study

5. Study Purpose

  • To evaluate the use of Vasopressin when given to pediatric patients in refractory cardiopulmonary arrest

6. What is Cardiopulmonary Arrest?

    • The person looses consciousness, stops breathing, and looses their pulse and blood pressure
    • All the organs of the body are receiving no blood flow and hence no oxygen
    • Cardiopulmonary resuscitation (CPR) is begun to help restart breathing and help the heart resume beating
    • Will lead to death if CPR not performed, may lead to death if CPR is performed

7. Can Cardiac Arrest be Reversed?

  • Brain death and permanent death start to occur in 4-6 minutes after cardiac arrest
  • Can be reversed if treated within MINUTES
  • Survival reduced by 7 to 10 percent with every minute that passes without CPR
  • Few attempts at resuscitation succeed after 10 minutes

8. How do we treat Cardiopulmonary Arrest?

  • Giving breaths and oxygen
  • Chest compressions
  • Defibrillation (electric shock to heart to restore normal heartbeat)
  • Medications to restart heart
  • Fluids
  • ? Resuscitation ECMO

9. Standard of Care for CPR

  • Pediatric Advanced Life
  • Support (PALS) Guidelines
  • - protocol endorsed by
  • the American Heart
  • Association for pediatric
  • patients

10. Standard of Care for CPR

  • Advanced Cardiac Life
  • Support (ACLS)
  • Guidelines
  • - protocol endorsed by
  • the American Heart
  • Association for adults

11. Standard of Care Limitations

  • Excessive medications can cause:
    • Severely increased blood pressure
    • Abnormal heart rhythms
    • Depressed heart function
  • Lack of oxygen and blood flow can cause:
    • Tissue damage to vital organs such as the brain, kidneys, intestines, and heart itself
    • Acid build up in the blood

12. Need for Improved Outcome

  • More than 95 percent of cardiac arrest victims die before reaching the hospital
  • Pediatric in-hospital cardiac arrest survival rate is extremely poor ~27%
  • Those who do survive may have severe brain injury

13. Need for Improved Outcome

  • To better understand how to treat cardiac arrest
  • Determine ways to improve survival after cardiac arrest

14. What is Vasopressin ?

  • Vasopressin is a drug approved by the Food and Drug Administration (FDA) for patients with:
      • Diabetes Insipidus(extreme thirst and frequent urination)
      • Abdominal distention after surgery

15.

  • Vasopressin is commonly used for the treatment of other disorders not currently approved by the FDA.
  • The use of Vasopressin in this manner is referred to as Off-Label

16. Current Standard of Care Off-Label

  • The use of Vasopressin is recognized:
    • By the American Heart Association and European Resuscitation Council for use in the management of adult patients in cardiac arrest
    • As a standard treatment for shock due to infection

17. Vasopressin Experience in CPR

  • In animal studies vasopressin has been shown to improve vital organ blood flow, particularly to the brain
  • Leads to improved outcomes to get the heart restarted and survive
  • Beneficial effects have been observed in adult human studies
  • ALL studies have shown vasopressin to be equal or superior to epinephrine (current standard of care)

18. Why Use Vasopressin ?

  • To improve the survival of pediatric patients during and after cardiac arrest
  • To understand the impact that Vasopressin has on the treatment of pediatric patients in cardiac arrest

19. Potential Benefits of Vasopressin

  • Increase the proportion of patients with return of a normal heart rate and blood pressure
  • Increase the likelihood of survival
  • Increase the proportion of patients with favorable neurologic outcome

20. FDA Review

  • Tia Tortoriello Raymond, M.D. received clearance to proceed with this study from the Food and Drug Administration (FDA)
  • The FDA authorized the use of exception from informed consent requirements for this study

21. Patient Protection

  • The Institutional Review Board (IRB) is a
  • group of medical, scientific, and nonscientific
  • members of the community
    • Reviews all proposals for research on humans
    • Assures patient safety
    • Monitors community feedback

22. Patient Protection

  • The UTSW IRB will decide whether or not to allow Childrens Medical Center to conduct the Vasopressin CPR trial BASED ON SCIENTIFIC MERIT AND COMMUNITY FEEDBACK
  • An independent data monitoring committee will oversee the trial
  • The FDA will be kept informed of the trials progress

23. What is Informed Consent?

  • Aprocess by which patients make informed decisions about participating in research studies.

24. Informed Consent

    • Traditionally required for all research studies
    • Research studies compare 2 treatments(standard vs. investigational)
    • Doctors describe each of these potential treatments
    • Patients are informed of the potential risks and potential benefits associated with each of these treatments
    • Patients choose whether to participate in the study

25. What is Exception from Informed Consent?

  • Patients are enrolled in a
  • research study without giving
  • their informed consent

26.

  • A federal regulation (21 CFR 50.24), created
  • in 1996, allows certain studies that meet the
  • following criteria to use this exception
    • Patients lives must be at risk
    • Available treatments are not satisfactory
    • Patients are unable to give consent
    • Potential risks are reasonable, participation in the research could provide a direct benefit(increased survival)to the patient
    • The research could not be practicably carried out without an exemption

http://www.fda.gov/ora/compliance_ref/bimo/err_guide.htm 27. Consent Safeguards

  • Obtaining consent is not feasible becauseintervention must be administered before consentfrom the subjects LAR is feasible.
  • Obtaining consent is not feasible as there isno reasonable way to identify prospective individualslikely to become eligible for participation.

28. Consent Safeguards

  • The IRB hasreviewed and approved the informed consent procedure and document .
  • Additional protections of the rights and welfare of subjects provided through a process ofcommunity consultation .
  • Additional protections of the rights and welfare of subjects provided through a process ofpublic disclosure.

29. Consent Safeguards

  • Procedures must be in place toinform at the
  • earliest feasible opportunityeach subject or
  • LAR of inclusion in the study.
  • The patient or a legally authorized representative may decide to withdraw the patient at any time without penalty or loss of benefits

30. Community Consultation

  • Community con