SIRAKI02
Trial question
What is the role of nonselective extracorporeal blood purification device connected to the cardiopulmonary bypass circuit in patients undergoing nonemergent cardiac surgery?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 343
343 patients (119 female, 224 male).
Inclusion criteria: adult patients undergoing nonemergent cardiac surgery who were at high risk for cardiac surgery-associated AKI.
Key exclusion criteria: immunosuppressive therapy or corticosteroids; autoimmune disorder; transplant recipient; advanced CKD; RRT in the past 90 days; documented intolerance to study device; pregnancy; coexisting illness with a high probability of death.
Interventions
N=169 extracorporeal blood purification (use of a nonselective extracorporeal blood purification device connected to the cardiopulmonary bypass circuit).
N=174 standard care (standard care during cardiopulmonary bypass).
Primary outcome
Rate of cardiac surgery-associated acute kidney injury by day 7
28.4%
39.7%
39.7 %
29.8 %
19.9 %
9.9 %
0.0 %
Extracorporeal blood
purification
Standard
care
Significant
decrease ▼
NNT = 8
Significant decrease in the rate of cardiac surgery-associated AKI by day 7 (28.4% vs. 39.7%; ARD -10.42, 95% CI -18.49 to -2.34).
Secondary outcomes
Borderline significant increase in ICU length of stay (3 days vs. 3 days).
Borderline significant decrease in survival at day 90 (95% vs. 96%; AD -1.3%, 95% CI -6.36 to 3.75).
Borderline significant increase in mean cardiopulmonary bypass duration (132 minutes vs. 127 minutes; AD 1 minutes, 95% CI -8 to 9).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients undergoing nonemergent cardiac surgery who were at high risk for cardiac surgery-associated AKI, extracorporeal blood purification was superior to standard care with respect to the rate of cardiac surgery-associated AKI by day 7.
Reference
Xosé Pérez-Fernández, Arnau Ulsamer, María Cámara-Rosell et al. Extracorporeal Blood Purification and Acute Kidney Injury in Cardiac Surgery: The SIRAKI02 Randomized Clinical Trial. JAMA. 2024 Oct 9. Online ahead of print.
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