Therapeutic Hypothermia after In-Hospital Cardiac Arrest in Children.
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Moler Frank W, Silverstein Faye S, Holubkov Richard, Slomine Beth S, Christensen James R, Nadkarni Vinay M, Meert Kathleen L, Browning Brittan, Pemberton Victoria L, Page Kent, Gildea Marianne R, Scholefield Barnaby R, Shankaran Seetha, Hutchison Jamie S, Berger John T, Ofori-Amanfo George, Newth Christopher J L, Topjian Alexis, Bennett Kimberly S, Koch Joshua D, Pham Nga, Chanani Nikhil K, Pineda Jose A, Harrison Rick, Dalton Heidi J, Alten Jeffrey, Schleien Charles L, Goodman Denise M, Zimmerman Jerry J, Bhalala Utpal S, Schwarz Adam J, Porter Melissa B, Shah Samir, Fink Ericka L, McQuillen Patrick, Wu Theodore, Skellett Sophie, Thomas Neal J, Nowak Jeffrey E, Baines Paul B, Pappachan John, Mathur Mudit, Lloyd Eric, van der Jagt Elise W, Dobyns Emily L, Meyer Michael T, Sanders Ronald C, Clark Amy E, Dean J Michael, THAPCA Trial Investigators
Аннотация
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 .).