THAPCA-OH
Therapeutic Hypothermia after Out-of-Hospital Cardiac Arrest in Children
Paciente / Población Intervención / Exposición Comparación Desenlace
In 295 comatose children after out-of-hospital cardiac arrest, hypothermia did not improve 1-year survival with good neurobehavioural function vs normothermia.
N
295
Diseño
Multicenter, randomized, controlled trial at 38 children's hospitals in the USA and Canada; comatose, ventilator-dependent children >48 hours to <18 years after out-of-hospital cardiac arrest with >=2 minutes of chest compressions were randomized within 6 hours of return of circulation to therapeutic hypothermia (33.0 degrees C for 48 hours, then rewarming) or therapeutic normothermia (36.8 degrees C), both maintained through 120 hours; 1355 screened, 475 eligible, enrolment September 2009 to December 2012.
Desenlace
Primary: survival with a Vineland Adaptive Behavior Scales, second edition (VABS-II) score of at least 70 at 12 months, assessed in the subgroup with a pre-arrest VABS-II score of at least 70.
ResultadoPrimary outcome 20% (27/138) with hypothermia vs 12% (15/122) with normothermia (relative risk 1.54, 95% CI 0.86-2.76; p=0.14). Survival at 12 months 38% vs 29% (p=0.13); change in VABS-II score did not differ (p=0.13). 28-day mortality 57% vs 67% (p=0.08). Within 7 days, blood product use 54% in both groups, culture-proven infection 46% vs 39% (p=0.28), serious arrhythmia 11% vs 9% (p=0.66).
Moler FW, et al. Therapeutic hypothermia after out-of-hospital cardiac arrest in children. N Engl J Med. 2015;372(20):1898-1908. 10.1056/nejmoa1411480