MedicalResearch.com Interview with:
Victoria Pemberton, RNC, MS, CCRC
Division of Cardiovascular Sciences
National Heart, Lung, and Blood Institute, NIH
MedicalResearch.com: What is the background for this study? What are the main findings?
- Previous studies have examined cardiac arrest when it occurs outside of the hospital in both children and adults, with current guidelines recommending hypothermia (body cooling) or normothermia (maintenance of normal body temperature) after such an arrest. This trial addresses pediatric cardiac arrest in a hospital setting, for which no previous data existed. Because children who experience an in-hospital cardiac arrest differ significantly from children who arrest outside of the hospital, it is important to test these treatments in this population.
- The trial found no significant differences in survival and neurobehavioral functioning a year after cardiac arrest between children assigned to the hypothermia arm and those assigned to normothermia.
MedicalResearch.com: What should readers take away from your report?
Response: Fever occurs commonly after cardiac arrest with hypoxic-ischemic brain injury. Preventing fever via an active intervention (either hypothermia or normothermia) may increase survival with good neurobehavioral outcome in children.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Investigation of a shorter therapeutic window to attain goal temperature is warranted, although may be difficult to achieve. A study of different durations of temperature control, and different depths of temperature control with or without neuroprotective pharmaceutical agents might be considered.
MedicalResearch.com: Is there anything else you would like to add?
- One important point is that this trial was terminated by the Data and Safety Monitoring Board (DSMB) prior to attainment of the target enrollment because of an assessment of futility, primarily due to low conditional power to show a significant treatment effect. The positive aspect of this is that resuscitation within pediatric hospitals is improving with the advent of rapid response teams and increasing focus on CPR skills, which lead to fewer eligible patients (children who remained dependent on mechanical ventilation after return of circulation) for this trial.
- Participants in this trial were managed under a strict protocol which may be challenging to replicate in a clinical care setting.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Frank W. Moler, M.D., Faye S. Silverstein, M.D., Richard Holubkov, Ph.D., Beth S. Slomine, Ph.D., James R. Christensen, M.D., Vinay M. Nadkarni, M.D., Kathleen L. Meert, M.D., Brittan Browning, M.S., R.D., C.C.R.C., Victoria L. Pemberton, R.N.C., M.S., Kent Page, M.Stat., Marianne R. Gildea, B.S.N., M.S., Barnaby R. Scholefield, M.B., B.S., Ph.D., Seetha Shankaran, M.D., Jamie S. Hutchison, M.D., John T. Berger, M.D., George Ofori-Amanfo, M.B., Ch.B., Christopher J.L. Newth, M.D., Alexis Topjian, M.D., Kimberly S. Bennett, M.D., M.P.H., Joshua D. Koch, M.D., Nga Pham, M.D., Nikhil K. Chanani, M.D., Jose A. Pineda, M.D., Rick Harrison, M.D., Heidi J. Dalton, M.D., Jeffrey Alten, M.D., Charles L. Schleien, M.D., Denise M. Goodman, M.D., Jerry J. Zimmerman, M.D., Ph.D., Utpal S. Bhalala, M.D., Adam J. Schwarz, M.D., Melissa B. Porter, M.D., Samir Shah, M.D., Ericka L. Fink, M.D., Patrick McQuillen, M.D., Theodore Wu, M.D., Sophie Skellett, M.B., B.S., M.R.C.P., Neal J. Thomas, M.D., Jeffrey E. Nowak, M.D., Paul B. Baines, M.D., Ph.D., John Pappachan, M.B., B.S., Mudit Mathur, M.D., Eric Lloyd, M.D., Elise W. van der Jagt, M.D., M.P.H., Emily L. Dobyns, M.D., Michael T. Meyer, M.D., Ronald C. Sanders, Jr., M.D., Amy E. Clark, M.S., and J. Michael Dean, M.D., for the THAPCA Trial Investigators*
N Engl J Med 2017; 376:318-329
January 26, 2017 DOI: 10.1056/NEJMoa1610493
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