Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery. (PROTection)

Università Vita-Salute San Raffaele

Status and phase

Completed

Phase 3

Conditions

Cardiac Surgery

Treatments

Drug: Amino Acids

Drug: Placebos

Study type

Interventional

Funder types

Other

Identifiers

NCT03709264

PROTection/47/OSR

Details and patient eligibility

About

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.

Enrollment

3,511 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.