A Phase 3 interventional study of Amino Acids and Placebos in Cardiac Surgery, sponsored by Università Vita-Salute San Raffaele. Completed at 22 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.
Sponsored by Università Vita-Salute San Raffaele · Phase 3, Interventional, and Treatment
To date, no pharmacological agents are proven efficacious in treating perioperative AKI. There is a strong biological rationale for the administration of amino acid in the management of patients at risk of AKI with increases in renal blood flow and GFR of 25 to 60% for several hours after the administration of amino acids (Woods LL 1993) mediated by a afferent arteriolar dilation.(Meyer TW 1983) Moreover, animal models have demonstrated that an increase in renal blood flow in response to a short-term amino acid infusion can protect the kidney from acute ischemic insults. Finally, these nephro-protective effects are preserved in critical illness. Cardiac surgery appears to be the best setting to test the likely beneficial renal effects of amino acid because of pathophysiological principles and the ability to intervene before the injury has begun. Although the etiology of AKI in cardiac surgery is multifactorial, renal hypoperfusion is believed to play a major role in this development by decreasing renal perfusion through a reduction in renal blood flow and through the activation of the sympathetic nervous system and the renin-angiotensin system with afferent arteriolar vasoconstriction. In this setting, a global increase in renal blood flow by means of Amino Acid therapy appears a logical and promising intervention.
The primary aim of the study is to determine whether providing continuous infusion of a balanced mixture of amino acids, compared to placebo (balanced crystalloid solution), reduces the incidence of acute kidney injury (AKI) in patients scheduled for cardiac surgery defined as KDIGO stage 1 or greater during hospital stay.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 3,511 is above the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Università Vita-Salute San Raffaele is the lead sponsor of 84 studies on the registry; 33 are open to participants now.
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Exclusion Criteria:
Drug: Amino Acids
Drug: Placebos
Patients randomized to experimental arm receive a continuous infusion of a balanced mixture of amino acids in a dose of 2 g/kg ideal body weight/day (to a maximum 100 g/day) from the operating room admission up to either death, start of RRT, ICU discharge or 72 hours after treatment initiation, trough a central venous line
Placebo: standard treatment
AKI incidence
Incidence of Acute Kidney Injury during hospital stay
Time frame: Until hospital discharge, an average of 10 days
Mortality
All-cause mortality at ICU discharge, hospital discharge, 30 and 90 and 180 days after randomization
Time frame: 180 days
RRT
Need and duration of renal replacement therapy
Time frame: 180 days
ICU stay
Duration of Intensive Care Unit stay
Time frame: Until ICU discharge, an average of 2 days
Hospital stay
Duration of hospital stay
Time frame: Until hospital discharge, an average of 10 days
Mechanical Ventilation
Need and duration of mechanical ventilation
Time frame: Until ICU discharge, an average of 2 days
EQ-5D
Quality of life at 180 days after randomization as measured by the EQ-5D
Time frame: 180 days
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Università Vita-Salute San Raffaele