PROTECTION
Trial question
What is the role of infusion of amino acids in patients undergoing cardiac surgery with cardiopulmonary bypass?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 3511
3511 patients (1057 female, 2454 male).
Inclusion criteria: adult patients who were scheduled to undergo cardiac surgery with cardiopulmonary bypass.
Key exclusion criteria: preoperative treatment or planned treatment with intermittent or continuous RRT; ≥ stage IV CKD.
Interventions
N=1759 amino acids (continuous infusion of a balanced mixture of amino acids at a dose of 2 g/kg/day for up to 3 days).
N=1752 placebo (continuous infusion of Ringer's solution for up to 3 days).
Primary outcome
Acute kidney injury
26.9%
31.7%
31.7 %
23.8 %
15.8 %
7.9 %
0.0 %
Amino
acids
Placebo
Significant
decrease ▼
NNT = 20
Significant decrease in AKI (26.9% vs. 31.7%; RR 0.85, 95% CI 0.77 to 0.94).
Secondary outcomes
No significant difference in RRT (1.4% vs. 1.9%; RR 0.73, 95% CI 0.43 to 1.22).
No significant difference in median duration of mechanical ventilation (11 hours vs. 11 hours; MD -0.6, 95% CI -3.7 to 2.49).
No significant difference in death at day 30 (2.8% vs. 2.8%; RR 1.02, 95% CI 0.69 to 1.5).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients who were scheduled to undergo cardiac surgery with cardiopulmonary bypass, amino acids were superior to placebo with respect to AKI.
Reference
Giovanni Landoni, Fabrizio Monaco, Lian Kah Ti et al. A Randomized Trial of Intravenous Amino Acids for Kidney Protection. N Engl J Med. 2024 Aug 22;391(8):687-698.
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