Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery.

Last updated: January 27, 2025
Sponsor: Università Vita-Salute San Raffaele
Overall Status: Completed

Phase

3

Condition

Cardiac Surgery

Treatment

Amino Acids

Placebos

Clinical Study ID

NCT03709264
PROTection/47/OSR
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age > 18 years

  • scheduled cardiac surgery

  • expected to stay in ICU at least 1 night after surgery

  • signed informed consent

Exclusion

Exclusion Criteria:

  • Patient currently enrolled into another randomized clinical trial

  • Patient currently receiving or scheduled for intermittent or continuous renalreplacement 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 aminoacids

  • Patient has a congenital alteration of amino acid metabolism

  • Pregnant or currently breastfeeding patients

  • Patients with any of the contraindications reported in the summary productcharacteristics.

Study Design

Total Participants: 3511
Treatment Group(s): 2
Primary Treatment: Amino Acids
Phase: 3
Study Start date:
October 07, 2019
Estimated Completion Date:
January 17, 2025

Connect with a study center

  • University Hospital Dubrava

    Dubrava,
    Croatia

    Site Not Available

  • Magdalena Clinic for Cardiovascular Diseases

    Zagreb,
    Croatia

    Site Not Available

  • Ospedale San Carlo

    Potenza, Basilicata
    Italy

    Site Not Available

  • Ospedale Mater Domini

    Catanzaro, Calabria
    Italy

    Site Not Available

  • Ospedale Monaldi

    Napoli, Campania
    Italy

    Site Not Available

  • Pineta Grande Hospital

    Castel Volturno, Caserta
    Italy

    Site Not Available

  • Azienda Ospedaliera Sant'Andrea

    Roma, Lazio
    Italy

    Site Not Available

  • Ospedale San Camillo

    Roma, Lazio
    Italy

    Site Not Available

  • IRCCS San Martino Istitute

    Genova, Liguria
    Italy

    Site Not Available

  • IRCCS Cardiologico Monzino

    Milano, Lombardy 20100
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, Lombardy
    Italy

    Site Not Available

  • IRCCS Ospedale San Donato

    Miano, Milano
    Italy

    Site Not Available

  • Città della Salute

    Torino, Piemonte
    Italy

    Site Not Available

  • Ospedale Ordine Mauriziano

    Torino, Piemonte
    Italy

    Site Not Available

  • Maria Cecilia Hospital

    Cotignola, Ravenna
    Italy

    Site Not Available

  • Ospedale del cuore - Fondazione Toscana Gabriele Monasterio

    Massa, Toscana
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • AOU Policlinico Paolo Giaccone

    Palermo,
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Pisana

    Pisa,
    Italy

    Site Not Available

  • Grande Ospedale Metropolitano

    Reggio Calabria,
    Italy

    Site Not Available

  • Ospedale Santa Maria della Misericordia

    Udine,
    Italy

    Site Not Available

  • National University Hospital

    Singapore,
    Singapore

    Site Not Available

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