TTM2 (original research)
Trial question
Is hypothermia superior to normothermia in patients with coma after out-of-hospital cardiac arrest?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 1861
1861 patients (384 female, 1477 male).
Inclusion criteria: adult patients with coma who had an out-of-hospital cardiac arrest.
Key exclusion criteria: interval from return of spontaneous circulation to screening of > 180 minutes; unwitnessed cardiac arrest with asystole as the initial rhythm; limitations in care.
Interventions
N=930 hypothermia (targeted temperature of 33 °C).
N=931 normothermia (targeted temperature ≤ 37.5 °C with early treatment of fever).
Primary outcome
Death from any cause at 6 months
50%
48%
50.0 %
37.5 %
25.0 %
12.5 %
0.0 %
Hypothermia
Normothermia
No significant
difference ↔
No significant difference in death from any cause at 6 months (50% vs. 48%; RR 1.04, 95% CI 0.94 to 1.14).
Secondary outcomes
No significant difference in patients with moderately severe disability or worse at 6 months (55% vs. 55%; RR 1, 95% CI 0.92 to 1.09).
No significant difference in patients with poor functional outcome at 6 months (54% vs. 54%; RR 1, 95% CI 0.91 to 1.08).
No significant difference in health-related QoL in patients who survived to 6 months (74 vs. 75; MD -0.8, 95% CI -3.6 to 2).
Safety outcomes
No significant differences in bleeding, pneumonia, and sepsis.
Significant difference in arrhythmias resulting in hemodynamic compromise (24% vs. 17%).
Conclusion
In adult patients with coma who had an out-of-hospital cardiac arrest, hypothermia was not superior to normothermia with respect to death from any cause at 6 months.
Reference
Josef Dankiewicz, Tobias Cronberg, Gisela Lilja et al. Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2021 Jun 17;384(24):2283-2294.
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