Vasopressin CPR Trial Community Consultation


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Vasopressin CPR Trial Community Consultation

  1. 1. Vasopressin CPR Trial Community Consultation Children’s Medical Center and The University of Texas Southwestern Medical Center
  2. 2. Principal Investigator <ul><li>Tia Tortoriello Raymond, M.D. </li></ul><ul><li>University of Texas Southwestern Medical Center </li></ul><ul><li>Children’s Medical Center Dallas </li></ul><ul><li>Department of Pediatrics </li></ul><ul><li>1935 Medical District Drive </li></ul><ul><li>Dallas, TX 75235 </li></ul><ul><li>(214) 456-2281 </li></ul>
  3. 3. Sub-investigator <ul><li>Timothy G. Carroll, M.D. </li></ul><ul><li>University of Texas Southwestern Medical Center </li></ul><ul><li>Children’s Medical Center Dallas </li></ul><ul><li>Department of Pediatrics </li></ul><ul><li>1935 Medical District Drive </li></ul><ul><li>Dallas, TX 75235 </li></ul><ul><li>(214) 456-7614 </li></ul>
  4. 4. Who is sponsoring the study and how many patients will be enrolled? <ul><li>The study is funded by the primary investigator and is not sponsored by industry </li></ul><ul><li>Approximately 130 subjects will be enrolled in this study </li></ul>
  5. 5. Study Purpose <ul><li>To evaluate the use of Vasopressin when given to pediatric patients in refractory cardiopulmonary arrest </li></ul>
  6. 6. What is Cardiopulmonary Arrest? <ul><ul><li>The person looses consciousness, stops breathing, and looses their pulse and blood pressure </li></ul></ul><ul><ul><li>All the organs of the body are receiving no blood flow and hence no oxygen </li></ul></ul><ul><ul><li>Cardiopulmonary resuscitation (CPR) is begun to help restart breathing and help the heart resume beating </li></ul></ul><ul><ul><li>Will lead to death if CPR not performed, may lead to death if CPR is performed </li></ul></ul>
  7. 7. Can Cardiac Arrest be Reversed? <ul><li>Brain death and permanent death start to occur in 4-6 minutes after cardiac arrest </li></ul><ul><li>Can be reversed if treated within MINUTES </li></ul><ul><li>Survival reduced by 7 to 10 percent with every minute that passes without CPR </li></ul><ul><li>Few attempts at resuscitation succeed after 10 minutes </li></ul>
  8. 8. How do we treat Cardiopulmonary Arrest? <ul><li>Giving breaths and oxygen </li></ul><ul><li>Chest compressions </li></ul><ul><li>Defibrillation (electric shock to heart to restore normal heartbeat) </li></ul><ul><li>Medications to restart heart </li></ul><ul><li>Fluids </li></ul><ul><li>? Resuscitation ECMO </li></ul>
  9. 9. Standard of Care for CPR <ul><li>Pediatric Advanced Life </li></ul><ul><li>Support (PALS) Guidelines </li></ul><ul><li>- protocol endorsed by </li></ul><ul><li>the American Heart </li></ul><ul><li>Association for pediatric </li></ul><ul><li>patients </li></ul>
  10. 10. Standard of Care for CPR <ul><li>Advanced Cardiac Life </li></ul><ul><li>Support (ACLS) </li></ul><ul><li>Guidelines </li></ul><ul><li>- protocol endorsed by </li></ul><ul><li>the American Heart </li></ul><ul><li>Association for adults </li></ul>
  11. 11. Standard of Care Limitations <ul><li>Excessive medications can cause: </li></ul><ul><ul><li>Severely increased blood pressure </li></ul></ul><ul><ul><li>Abnormal heart rhythms </li></ul></ul><ul><ul><li>Depressed heart function </li></ul></ul><ul><li>Lack of oxygen and blood flow can cause: </li></ul><ul><ul><li>Tissue damage to vital organs such as the brain, kidneys, intestines, and heart itself </li></ul></ul><ul><ul><li>Acid build up in the blood </li></ul></ul>
  12. 12. Need for Improved Outcome <ul><li>More than 95 percent of cardiac arrest victims die before reaching the hospital </li></ul><ul><li>Pediatric in-hospital cardiac arrest survival rate is extremely poor ~27% </li></ul><ul><li>Those who do survive may have severe brain injury </li></ul>
  13. 13. Need for Improved Outcome <ul><li>To better understand how to treat cardiac arrest </li></ul><ul><li>Determine ways to improve survival after cardiac arrest </li></ul>
  14. 14. What is Vasopressin ? <ul><li>Vasopressin is a drug approved by the Food and Drug Administration (FDA) for patients with: </li></ul><ul><ul><ul><li>Diabetes Insipidus (extreme thirst and frequent urination) </li></ul></ul></ul><ul><ul><ul><li>Abdominal distention after surgery </li></ul></ul></ul>
  15. 15. <ul><li>Vasopressin is commonly used for the treatment of other disorders not currently approved by the FDA. </li></ul><ul><li>The use of Vasopressin in this manner is referred to as “Off-Label” </li></ul>
  16. 16. Current Standard of Care “Off-Label” <ul><li>The use of Vasopressin is recognized: </li></ul><ul><ul><li>By the American Heart Association and European Resuscitation Council for use in the management of adult patients in cardiac arrest </li></ul></ul><ul><ul><li>As a standard treatment for shock due to infection </li></ul></ul>
  17. 17. Vasopressin Experience in CPR <ul><li>In animal studies vasopressin has been shown to improve vital organ blood flow, particularly to the brain </li></ul><ul><li>Leads to improved outcomes to get the heart restarted and survive </li></ul><ul><li>Beneficial effects have been observed in adult human studies </li></ul><ul><li>ALL studies have shown vasopressin to be equal or superior to epinephrine (current standard of care) </li></ul>
  18. 18. Why Use Vasopressin ? <ul><li>To improve the survival of pediatric patients during and after cardiac arrest </li></ul><ul><li>To understand the impact that Vasopressin has on the treatment of pediatric patients in cardiac arrest </li></ul>
  19. 19. Potential Benefits of Vasopressin <ul><li>Increase the proportion of patients with return of a normal heart rate and blood pressure </li></ul><ul><li>Increase the likelihood of survival </li></ul><ul><li>Increase the proportion of patients with favorable neurologic outcome </li></ul>
  20. 20. FDA Review <ul><li>Tia Tortoriello Raymond, M.D. received clearance to proceed with this study from the Food and Drug Administration (FDA) </li></ul><ul><li>The FDA authorized the use of exception from informed consent requirements for this study </li></ul>
  21. 21. Patient Protection <ul><li>The Institutional Review Board (IRB) is a </li></ul><ul><li>group of medical, scientific, and nonscientific </li></ul><ul><li>members of the community </li></ul><ul><ul><li>Reviews all proposals for research on humans </li></ul></ul><ul><ul><li>Assures patient safety </li></ul></ul><ul><ul><li>Monitors community feedback </li></ul></ul>
  22. 22. Patient Protection <ul><li>The UTSW IRB will decide whether or not to allow Children’s Medical Center to conduct the Vasopressin CPR trial BASED ON SCIENTIFIC MERIT AND COMMUNITY FEEDBACK </li></ul><ul><li>An independent data monitoring committee will oversee the trial </li></ul><ul><li>The FDA will be kept informed of the trial’s progress </li></ul>
  23. 23. What is Informed Consent? <ul><li>A process by which patients make informed decisions about participating in research studies. </li></ul>
  24. 24. Informed Consent <ul><ul><li>Traditionally required for all research studies </li></ul></ul><ul><ul><li>Research studies compare 2 treatments (standard vs. investigational) </li></ul></ul><ul><ul><li>Doctors describe each of these potential treatments </li></ul></ul><ul><ul><li>Patients are informed of the potential risks and potential benefits associated with each of these treatments </li></ul></ul><ul><ul><li>Patients choose whether to participate in the study </li></ul></ul>
  25. 25. What is Exception from Informed Consent? <ul><li>Patients are enrolled in a </li></ul><ul><li>research study without giving </li></ul><ul><li>their informed consent </li></ul>
  26. 26. <ul><li>A federal regulation (21 CFR 50.24), created </li></ul><ul><li>in 1996, allows certain studies that meet the </li></ul><ul><li>following criteria to use this exception </li></ul><ul><ul><li>Patients’ lives must be at risk </li></ul></ul><ul><ul><li>Available treatments are not satisfactory </li></ul></ul><ul><ul><li>Patients are unable to give consent </li></ul></ul><ul><ul><li>Potential risks are reasonable, participation in the research could provide a direct benefit (increased survival) to the patient </li></ul></ul><ul><ul><li>The research could not be practicably carried out without an exemption </li></ul></ul>
  27. 27. Consent Safeguards <ul><li>Obtaining consent is not feasible because intervention must be administered before consent from the subject’s LAR is feasible. </li></ul><ul><li>Obtaining consent is not feasible as there is no reasonable way to identify prospective individuals likely to become eligible for participation. </li></ul>
  28. 28. Consent Safeguards <ul><li>The IRB has reviewed and approved the informed consent procedure and document . </li></ul><ul><li>Additional protections of the rights and welfare of subjects provided through a process of community consultation . </li></ul><ul><li>Additional protections of the rights and welfare of subjects provided through a process of public disclosure. </li></ul>
  29. 29. Consent Safeguards <ul><li>Procedures must be in place to inform at the </li></ul><ul><li>earliest feasible opportunity each subject or </li></ul><ul><li>LAR of inclusion in the study. </li></ul><ul><li>The patient or a legally authorized representative may decide to withdraw the patient at any time without penalty or loss of benefits </li></ul>
  30. 30. Community Consultation <ul><li>Community consultation refers to ensuring the communities involved are provided an opportunity to discuss the proposed clinical investigation. </li></ul><ul><li>Following completion of the study information about the study results must be disclosed </li></ul><ul><ul><li>to the community where the research was done </li></ul></ul><ul><ul><li>the research community should have access to comprehensive summary data </li></ul></ul>
  31. 31. Community Consultation <ul><li>Must advise the “community at risk” of the study and ways to “opt out” </li></ul><ul><ul><li>For in-hospital resuscitation study this community would be the families/staff of the Pediatric ICU at CMC </li></ul></ul><ul><ul><li>Focus group discussions with physicians, nurses, pharmacists, families </li></ul></ul><ul><ul><li>Posters, brochures, website and study personnel available to explain the study in the PICU </li></ul></ul><ul><ul><li>Press release and letter to all medical staff </li></ul></ul>
  32. 32. Procedure to “Opt Out” <ul><li>If a parent decides to “opt out” of the study, a sign will be placed on the patient’s bed that will clearly delineate that the patient is not included in the study. </li></ul>
  33. 33. Public Disclosure <ul><li>Public disclosure refers to informing these communities about the study prior to starting and following completion. </li></ul><ul><li>Prior to start of the study -- public disclosure of sufficient information to describe : </li></ul><ul><ul><li>the nature and purpose of the study </li></ul></ul><ul><ul><li>the fact that informed consent will not be obtained for most study subjects </li></ul></ul>
  34. 34. <ul><li>Patients will be randomly assigned to either one of two groups (like flipping a coin) </li></ul><ul><li>Control Test </li></ul><ul><ul><li>Epinephrine Only </li></ul></ul><ul><ul><li>(standard of care) </li></ul></ul>Trial Design: After patient suffers a cardiac arrest Epinephrine and Vasopressin 50% 50%
  35. 35. Who Would Be Included? <ul><li>Patients who suffer a cardiac arrest in the Pediatric Intensive Care Unit </li></ul><ul><li>Who are 0-18 years old </li></ul><ul><li>Who require more than one dose of a medication to restart the heart </li></ul>
  36. 36. Who Would Be Excluded? <ul><li>Patients who do not require chest compressions or defibrillation </li></ul><ul><li>Patients who do not require epinephrine </li></ul><ul><li>Patients who are pregnant </li></ul><ul><li>Patients with known orders not to resuscitate </li></ul><ul><li>Patients in the custody of the State of Texas </li></ul><ul><li>Any patient whose parent or guardian “opts out” of the study </li></ul><ul><li>Any patient whose attending physician “opts out” of the study </li></ul>
  37. 37. Potential Risks of Vasopressin <ul><li>The risks of vasopressin are equal or less than the risks associated with epinephrine (current standard of care) </li></ul><ul><li>Risks include: </li></ul><ul><ul><ul><li>Increase in liver enzymes, decrease in platelets (helps blood clot) </li></ul></ul></ul><ul><ul><ul><li>Abnormal heart rhythm, low sodium, allergic reaction, and skin necrosis if the medications leaks out of the vein </li></ul></ul></ul><ul><ul><ul><li>Increase in urine output </li></ul></ul></ul><ul><ul><ul><li>Unforeseen happenings </li></ul></ul></ul>
  38. 38. After the study is completed… <ul><li>The results of the study will be revealed to the community after the trial has been completed </li></ul><ul><li>The results of this study could change the protocol by which every pediatric patient that experiences cardiac arrest is resuscitated </li></ul>
  39. 39. Questions or Comments? Phone Number: (214) 456-7614 or (214) 456-2281
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