THAPCA-IH
Trial question
What is the role of therapeutic hypothermia in comatose children who survived in-hospital cardiac arrest?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 329
329 patients (133 female, 196 male).
Inclusion criteria: pediatric patients who had had in-hospital cardiac arrest, received chest compressions for at least 2 minutes, and remained dependent on mechanical ventilation after the return of circulation.
Key exclusion criteria: a score of 5-6 on the GCS motor-response subscale; inability to undergo randomization within 6 hours after the return of circulation; active and refractory severe bleeding; preexisting illness associated with a life expectancy of < 12 months; decision to withhold aggressive treatment.
Interventions
N=166 therapeutic hypothermia (target temperature 33.0 °C).
N=163 therapeutic normothermia (target temperature 36.8 °C).
Primary outcome
Survival at 12 months with a score of ≥ 70 on Vineland Adaptive Behavior Scales second edition
36%
39%
39.0 %
29.3 %
19.5 %
9.8 %
0.0 %
Therapeutic
hypothermia
Therapeutic
normothermia
No significant
difference ↔
No significant difference in survival at 12 months with a score of ≥ 70 on the Vineland Adaptive Behavior Scales second edition (36% vs. 39%; RR 0.92, 95% CI 0.67 to 1.27).
Secondary outcomes
No significant difference in survival at 1 year (49% vs. 46%; RR 1.07, 95% CI 0.85 to 1.34).
Safety outcomes
No significant differences in death at 28 days, incidence of infection, blood product use, and serious arrhythmias within 7 days after randomization.
Conclusion
In pediatric patients who had had in-hospital cardiac arrest, received chest compressions for at least 2 minutes, and remained dependent on mechanical ventilation after the return of circulation, therapeutic hypothermia was not superior to therapeutic normothermia with respect to survival at 12 months with a score of ≥ 70 on the Vineland Adaptive Behavior Scales second edition.
Reference
Frank W Moler, Faye S Silverstein, Richard Holubkov et al. Therapeutic Hypothermia after In-Hospital Cardiac Arrest in Children. N Engl J Med. 2017 Jan 26;376(4):318-329.
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