GOT ICE (deep vs. high-moderate hypothermia)
Trial question
Is deep hypothermia superior to high-moderate hypothermia in patients with hypothermic circulatory arrest during aortic arch surgery?
Study design
Multi-center
Single blinded
RCT
Population
Characteristics of study participants
22.0% female
78.0% male
N = 186
186 patients (40 female, 146 male).
Inclusion criteria: patients undergoing aortic arch surgery with hypothermic circulatory arrest plus antegrade cerebral perfusion.
Key exclusion criteria: age < 18 years; history of symptomatic cerebrovascular disease; alcohol use disorder; psychiatric illness; drug abuse; hepatic insufficiency; severe pulmonary insufficiency; renal failure; claustrophobic fear.
Interventions
N=94 deep hypothermia (temperature ≤ 20 °C).
N=92 high-moderate hypothermia (temperature 24.1-28.0 °C).
Primary outcome
Decline in global cognitive scores at week 4 postoperatively
-0.01 points
0.05 points
0.0 points
-0.0 points
-0.0 points
-0.0 points
-0.1 points
Deep
hypothermia
High-moderate
hypothermia
No significant
difference ↔
No significant difference in decline in global cognitive scores at week 4 postoperatively (-0.01 points vs. 0.05 points; MD 0.06, 97.5% CI -0.07 to 0.19).
Secondary outcomes
Significantly greater improvement in structured verbal memory (0.33 points vs. 0.02 points; MD 0.31, 97.5% CI 0.02 to 0.61).
No significant difference in postoperative delirium (29.7% vs. 35.9%; RR 0.83, 95% CI -0.96 to 2.62).
Safety outcomes
No significant differences in serious adverse event in the hospital, death at day 30.
Conclusion
In patients undergoing aortic arch surgery with hypothermic circulatory arrest plus antegrade cerebral perfusion, deep hypothermia was not superior to high-moderate hypothermia with respect to decline in global cognitive scores at week 4 postoperatively.
Reference
G Chad Hughes, Edward P Chen, Jeffrey N Browndyke et al. Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest Trial (GOT ICE): A Randomized Clinical Trial Comparing Outcomes After Aortic Arch Surgery. Circulation. 2024 Feb 27;149(9):658-668.
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