Frank W Moler1, Faye S Silverstein1, Richard Holubkov1, Beth S Slomine1, James R Christensen1, Vinay M Nadkarni1, Kathleen L Meert1, Brittan Browning1, Victoria L Pemberton1, Kent Page1, Marianne R Gildea1, Barnaby R Scholefield1, Seetha Shankaran1, Jamie S Hutchison1, John T Berger1, George Ofori-Amanfo1, Christopher J L Newth1, Alexis Topjian1, Kimberly S Bennett1, Joshua D Koch1, Nga Pham1, Nikhil K Chanani1, Jose A Pineda1, Rick Harrison1, Heidi J Dalton1, Jeffrey Alten1, Charles L Schleien1, Denise M Goodman1, Jerry J Zimmerman1, Utpal S Bhalala1, Adam J Schwarz1, Melissa B Porter1, Samir Shah1, Ericka L Fink1, Patrick McQuillen1, Theodore Wu1, Sophie Skellett1, Neal J Thomas1, Jeffrey E Nowak1, Paul B Baines1, John Pappachan1, Mudit Mathur1, Eric Lloyd1, Elise W van der Jagt1, Emily L Dobyns1, Michael T Meyer1, Ronald C Sanders1, Amy E Clark1, J Michael Dean1. 1. From the University of Michigan, Ann Arbor (F.W.M., F.S.S.), and Wayne State University, Detroit (K.L.M., S. Shankaran) - both in Michigan; University of Utah, Salt Lake City (R. Holubkov, B.B., K.P., M.R.G., K.S.B., A.E.C., J.M.D.); Kennedy Krieger Institute and Johns Hopkins University (B.S.S., J.R.C.) and Johns Hopkins Children's Center (U.S.B.), Baltimore, and the National Heart, Lung, and Blood Institute, Bethesda (V.L.P.) - both in Maryland; Children's Hospital of Philadelphia, Philadelphia (V.M.N., A.T.), University of Pittsburgh Medical Center, Pittsburgh (E.L.F.), and Penn State Children's Hospital, Hershey (N.J.T.) - all in Pennsylvania; Birmingham Children's Hospital, Birmingham (B.R.S.), Great Ormond Street Hospital, London (S. Skellett), Alder Hey Children's Hospital, Liverpool (P.B.B.), and University Hospital Southampton, Southampton (J.P.) - all in the United Kingdom; Hospital for Sick Children, Toronto (J.S.H.); Children's National Medical Center, Washington, DC (J.T.B.); Duke Children's Hospital, Durham, NC (G.O.-A.); Children's Hospital Los Angeles (C.J.L.N.) and Mattel Children's Hospital UCLA (R. Harrison), Los Angeles, Children's Hospital of Orange County, Orange (A.J.S.), University of California, San Francisco Benioff Children's Hospital, San Francisco (P.M.), and Loma Linda University Children's Hospital, Loma Linda (M.M.) - all in California; Children's Medical Center Dallas, University of Texas Southwestern Medical School, Dallas (J.D.K.); University of Texas Health Sciences Center at San Antonio, San Antonio (T.W.); Children's Healthcare of Atlanta, Atlanta (N.P., N.K.C.); Washington University, St. Louis (J.A.P.); Phoenix Children's Hospital, Phoenix, AZ (H.J.D.); the Children's Hospital of Alabama, Birmingham (J.A.); Children's Hospital of New York, Columbia University Medical Center, New York (C.L.S.), and Golisano Children's Hospital, University of Rochester Medical Center, Rochester (E.W.J.) - both in New York; Ann and Robert Lurie Children's Hospital of Chicago, Chicago (D.M.G.); Seattle Children's Hospital, Seattle (J.J.Z.); Kosair Children's Hospital, University of Louisville, Louisville, KY (M.B.P.); University of Tennessee Health Science Center, Memphis (S. Shah); Children's Hospital and Clinics of Minnesota, Minneapolis (J.E.N.); Nationwide Children's Hospital, Columbus, OH (E.L.); Children's Hospital Colorado, Aurora (E.L.D.); Medical College of Wisconsin, Milwaukee (M.T.M.); and Arkansas Children's Hospital, Little Rock (R.C.S.).
Abstract
BACKGROUND: Targeted temperature management is recommended for comatose adults and children after out-of-hospital cardiac arrest; however, data on temperature management after in-hospital cardiac arrest are limited. METHODS: In a trial conducted at 37 children's hospitals, we compared two temperature interventions in children who had had in-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose children older than 48 hours 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 score of 70 or higher on the Vineland Adaptive Behavior Scales, second edition (VABS-II, on which scores range from 20 to 160, with higher scores indicating better function), was evaluated among patients who had had a VABS-II score of at least 70 before the cardiac arrest. RESULTS: The trial was terminated because of futility after 329 patients had undergone randomization. Among the 257 patients who had a VABS-II score of at least 70 before cardiac arrest and who could be evaluated, the rate of the primary efficacy outcome did not differ significantly between the hypothermia group and the normothermia group (36% [48 of 133 patients] and 39% [48 of 124 patients], respectively; relative risk, 0.92; 95% confidence interval [CI], 0.67 to 1.27; P=0.63). Among 317 patients who could be evaluated for change in neurobehavioral function, the change in VABS-II score from baseline to 12 months did not differ significantly between the groups (P=0.70). Among 327 patients who could be evaluated for 1-year survival, the rate of 1-year survival did not differ significantly between the hypothermia group and the normothermia group (49% [81 of 166 patients] and 46% [74 of 161 patients], respectively; relative risk, 1.07; 95% CI, 0.85 to 1.34; P=0.56). The incidences of blood-product use, infection, and serious adverse events, as well as 28-day mortality, did not differ significantly between groups. CONCLUSIONS: Among comatose children who survived in-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a favorable functional outcome at 1 year. (Funded by the National Heart, Lung, and Blood Institute; THAPCA-IH ClinicalTrials.gov number, NCT00880087 .).
BACKGROUND: Targeted temperature management is recommended for comatose adults and children after out-of-hospital cardiac arrest; however, data on temperature management after in-hospital cardiac arrest are limited. METHODS: In a trial conducted at 37 children's hospitals, we compared two temperature interventions in children who had had in-hospital cardiac arrest. Within 6 hours after the return of circulation, comatose children older than 48 hours 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 score of 70 or higher on the Vineland Adaptive Behavior Scales, second edition (VABS-II, on which scores range from 20 to 160, with higher scores indicating better function), was evaluated among patients who had had a VABS-II score of at least 70 before the cardiac arrest. RESULTS: The trial was terminated because of futility after 329 patients had undergone randomization. Among the 257 patients who had a VABS-II score of at least 70 before cardiac arrest and who could be evaluated, the rate of the primary efficacy outcome did not differ significantly between the hypothermia group and the normothermia group (36% [48 of 133 patients] and 39% [48 of 124 patients], respectively; relative risk, 0.92; 95% confidence interval [CI], 0.67 to 1.27; P=0.63). Among 317 patients who could be evaluated for change in neurobehavioral function, the change in VABS-II score from baseline to 12 months did not differ significantly between the groups (P=0.70). Among 327 patients who could be evaluated for 1-year survival, the rate of 1-year survival did not differ significantly between the hypothermia group and the normothermia group (49% [81 of 166 patients] and 46% [74 of 161 patients], respectively; relative risk, 1.07; 95% CI, 0.85 to 1.34; P=0.56). The incidences of blood-product use, infection, and serious adverse events, as well as 28-day mortality, did not differ significantly between groups. CONCLUSIONS: Among comatose children who survived in-hospital cardiac arrest, therapeutic hypothermia, as compared with therapeutic normothermia, did not confer a significant benefit in survival with a favorable functional outcome at 1 year. (Funded by the National Heart, Lung, and Blood Institute; THAPCA-IH ClinicalTrials.gov number, NCT00880087 .).
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