TY - JOUR
T1 - Therapeutic hypothermia after out-of-hospital cardiac arrest in children
AU - Moler, Frank W.
AU - Silverstein, Faye S.
AU - Holubkov, Richard
AU - Slomine, Beth S.
AU - Christensen, James R.
AU - Nadkarni, Vinay M.
AU - Meert, Kathleen L.
AU - Clark, Amy E.
AU - Browning, Brittan
AU - Pemberton, Victoria L.
AU - Page, Kent
AU - Shankaran, Seetha
AU - Hutchison, Jamie S.
AU - Newth, Christopher J.L.
AU - Bennett, Kimberly S.
AU - Berger, John T.
AU - Topjian, Alexis
AU - Pineda, Jose A.
AU - Koch, Joshua D.
AU - Schleien, Charles L.
AU - Dalton, Heidi J.
AU - Ofori-Amanfo, George
AU - Goodman, Denise M.
AU - Fink, Ericka L.
AU - McQuillen, Patrick
AU - Zimmerman, Jerry J.
AU - Thomas, Neal J.
AU - Van Der Jagt, Elise W.
AU - Porter, Melissa B.
AU - Meyer, Michael T.
AU - Harrison, Rick
AU - Pham, Nga
AU - Schwarz, Adam J.
AU - Nowak, Jeffrey E.
AU - Alten, Jeffrey
AU - Wheeler, Derek S.
AU - Bhalala, Utpal S.
AU - Lidsky, Karen
AU - Lloyd, Eric
AU - Mathur, Mudit
AU - Shah, Samir
AU - Wu, Theodore
AU - Theodorou, Andreas A.
AU - Sanders, Ronald C.
AU - Dean, J. Michael
N1 - Publisher Copyright:
Copyright © 2015 Massachusetts Medical Society.
PY - 2015/5/14
Y1 - 2015/5/14
N2 - Background: Therapeutic hypothermia is recommended for comatose adults after witnessed outofhospital cardiac arrest, but data about this intervention in children are limited. Methods: We conducted this trial of two targeted temperature interventions at 38 children's hospitals involving children who remained unconscious after out-of-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose patients who were older than 2 days and younger than 18 years of age were randomly assigned to therapeutic hypothermia (target temperature, 33.0°C) or therapeutic normothermia (target temperature, 36.8°C). The primary efficacy outcome, survival at 12 months after cardiac arrest with a Vineland Adaptive Behavior Scales, second edition (VABS-II), score of 70 or higher (on a scale from 20 to 160, with higher scores indicating better function), was evaluated among patients with a VABS-II score of at least 70 before cardiac arrest. Results: A total of 295 patients underwent randomization. Among the 260 patients with data that could be evaluated and who had a VABS-II score of at least 70 before cardiac arrest, there was no significant difference in the primary outcome between the hypothermia group and the normothermia group (20% vs. 12%; relative likelihood, 1.54; 95% confidence interval [CI], 0.86 to 2.76; P = 0.14). Among all the patients with data that could be evaluated, the change in the VABS-II score from baseline to 12 months was not significantly different (P = 0.13) and 1-year survival was similar (38% in the hypothermia group vs. 29% in the normothermia group; relative likelihood, 1.29; 95% CI, 0.93 to 1.79; P = 0.13). The groups had similar incidences of infection and serious arrhythmias, as well as similar use of blood products and 28-day mortality. Conclusions: In comatose children who survived out-of-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a good functional outcome at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; THAPCA-OH ClinicalTrials.gov number, NCT00878644.)
AB - Background: Therapeutic hypothermia is recommended for comatose adults after witnessed outofhospital cardiac arrest, but data about this intervention in children are limited. Methods: We conducted this trial of two targeted temperature interventions at 38 children's hospitals involving children who remained unconscious after out-of-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose patients who were older than 2 days and younger than 18 years of age were randomly assigned to therapeutic hypothermia (target temperature, 33.0°C) or therapeutic normothermia (target temperature, 36.8°C). The primary efficacy outcome, survival at 12 months after cardiac arrest with a Vineland Adaptive Behavior Scales, second edition (VABS-II), score of 70 or higher (on a scale from 20 to 160, with higher scores indicating better function), was evaluated among patients with a VABS-II score of at least 70 before cardiac arrest. Results: A total of 295 patients underwent randomization. Among the 260 patients with data that could be evaluated and who had a VABS-II score of at least 70 before cardiac arrest, there was no significant difference in the primary outcome between the hypothermia group and the normothermia group (20% vs. 12%; relative likelihood, 1.54; 95% confidence interval [CI], 0.86 to 2.76; P = 0.14). Among all the patients with data that could be evaluated, the change in the VABS-II score from baseline to 12 months was not significantly different (P = 0.13) and 1-year survival was similar (38% in the hypothermia group vs. 29% in the normothermia group; relative likelihood, 1.29; 95% CI, 0.93 to 1.79; P = 0.13). The groups had similar incidences of infection and serious arrhythmias, as well as similar use of blood products and 28-day mortality. Conclusions: In comatose children who survived out-of-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a good functional outcome at 1 year. (Funded by the National Heart, Lung, and Blood Institute and others; THAPCA-OH ClinicalTrials.gov number, NCT00878644.)
UR - http://www.scopus.com/inward/record.url?scp=84929376769&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84929376769&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1411480
DO - 10.1056/NEJMoa1411480
M3 - Article
C2 - 25913022
AN - SCOPUS:84929376769
SN - 0028-4793
VL - 372
SP - 1898
EP - 1908
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 20
ER -