PROTECTION (secondary analysis)
Trial question
What is the role of infusion of amino acids in patients with CKD undergoing cardiopulmonary bypass?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
49.0% female
51.0% male
N = 812
812 patients (399 female, 413 male).
Inclusion criteria: patients with CKD undergoing cardiopulmonary bypass.
Key exclusion criteria: RRT; kidney transplant; GFR < 30 mL/min/1.73 m²; not expected to survive ICU or hospital discharge; severe liver disease; hypersensitivity to amino acids; congenital alteration of amino acid metabolism; pregnancy or breastfeeding.
Interventions
N=404 amino acids (continuous infusion of a balanced mixture of amino acids [Isopuramin® 10%] at a dose of 2 g/kg/day, up to a maximum of 100 g/day, for up to 3 days).
N=408 placebo (continuous infusion of Ringer's solution for up to 3 days).
Primary outcome
Acute kidney injury
43.1%
50.3%
50.3 %
37.7 %
25.1 %
12.6 %
0.0 %
Amino
acids
Placebo
Significant
decrease ▼
NNT = 13
Significant decrease in AKI (43.1% vs. 50.3%; RR 0.86, 95% CI 0.74 to 0.99).
Secondary outcomes
No significant difference in RRT (2.2% vs. 3.7%; RR 0.6, 95% CI 0.27 to 1.37).
Significant decrease in severe AKI (2.7% vs. 5.6%; RR 0.48, 95% CI 0.24 to 0.98).
No significant difference in death at day 180 (8.3% vs. 6.8%; RR 1.22, 95% CI 0.75 to 1.98).
Conclusion
In patients with CKD undergoing cardiopulmonary bypass, amino acids were superior to placebo with respect to AKI.
Reference
Martina Baiardo Redaelli, Fabrizio Monaco, Nikola Bradic et al. Amino Acid Infusion for Kidney Protection in Cardiac Surgery Patients with Chronic Kidney Disease: A Secondary Analysis of the PROTECTION Trial. Anesthesiology. 2025 May 1;142(5):818-828.
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