Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery: a Multi-centre Randomized Blinded Placebo Controlled Clinical Trial.

PROTection/47/OSR

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.

2019-10-07

2024-01-17

2024-07-01

Active (not recruiting)

Early phase I

3511

Inclusion Criteria: * age \> 18 years * scheduled cardiac surgery * expected to stay in ICU at least 1 night after surgery * signed informed consent Exclusion Criteria: * Patient currently enrolled into another randomized clinical trial * Patient currently receiving or scheduled for intermittent or continuous renal replacement therapy * Patients with CKD of equal or more than CKD stage IV (GFR\<30 ml/min/1.73 m2) * Patient with a kidney transplant * Patient is not expected to survive ICU or hospital discharge * Patient previously been enrolled and randomized into this study * Patient has severe liver disease (Child-Pugh score \>7 points) * Patient has a hypersensitivity (known allergy) to one or more of the included amino acids * Patient has a congenital alteration of amino acid metabolism * Pregnant or currently breastfeeding patients * Patients with any of the contraindications reported in the summary product characteristics.

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2024-04-05