ROCS
Trial question
What is the role of intraoperative hyperoxia in patients undergoing open cardiac surgery?
Study design
Single center
Single blinded
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 200
200 patients (60 female, 140 male).
Inclusion criteria: patients undergoing open cardiac surgery.
Key exclusion criteria: acute coronary syndrome; preoperative oxygen requirement; carotid artery stenosis; dialysis; cardiac surgery requiring intraoperative circulatory arrest; pregnancy.
Interventions
N=100 hyperoxia (FiO2 1.0 administered during surgery).
N=100 normoxia (minimum FiO2 administered during surgery to maintain oxygen saturation 95-97%).
Primary outcome
Median elevation in serum creatinine on postoperative day 2
0.88
-0.88
0.9 mcmol/L
0.7 mcmol/L
0.4 mcmol/L
0.2 mcmol/L
0.0 mcmol/L
-0.2 mcmol/L
-0.4 mcmol/L
-0.7 mcmol/L
-0.9 mcmol/L
Hyperoxia
Normoxia
No significant
difference ↔
No significant difference in median elevation in serum creatinine on postoperative day 2 (0.88 mcmol/L vs. -0.88 mcmol/L; MD 2.65, 95% CI -3.54 to 8.84).
Secondary outcomes
No significant difference in moderate or severe AKI (2% vs. 5%; MRD -3, 95% CI -8.1 to 2.1).
No significant difference in AF (46% vs. 37%; MD 9, 95% CI -4.6 to 22.6).
Safety outcomes
No significant differences in TIA, stroke, death, and tracheal reintubation.
Significant difference in hypoxemia during ventilation (24% vs. 75%).
Conclusion
In patients undergoing open cardiac surgery, hyperoxia was not superior to normoxia with respect to median elevation in serum creatinine on postoperative day 2.
Reference
Marcos G Lopez, Matthew S Shotwell, Cassandra Hennessy et al. Intraoperative Oxygen Treatment, Oxidative Stress, and Organ Injury Following Cardiac Surgery: A Randomized Clinical Trial. JAMA Surg. 2024 Aug 7:e242906.
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