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Completed

NCT Number: NCT03709264

Intravenous Amino Acid Therapy for Kidney Protection in Cardiac Surgery.

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Dubrava, Dubrava, Croatia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amino Acids

Drug

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

Placebos

Drug

Placebo: standard treatment

Primary outcomes

  1. AKI incidence

    Time frame: Until hospital discharge, an average of 10 days

    Incidence of Acute Kidney Injury during hospital stay

Secondary outcomes

  1. Mortality

    Time frame: 180 days

    All-cause mortality at ICU discharge, hospital discharge, 30 and 90 and 180 days after randomization

  2. RRT

    Time frame: 180 days

    Need and duration of renal replacement therapy

  3. ICU stay

    Time frame: Until ICU discharge, an average of 2 days

    Duration of Intensive Care Unit stay

  4. Hospital stay

    Time frame: Until hospital discharge, an average of 10 days

    Duration of hospital stay

  5. Mechanical Ventilation

    Time frame: Until ICU discharge, an average of 2 days

    Need and duration of mechanical ventilation

  6. EQ-5D

    Time frame: 180 days

    Quality of life at 180 days after randomization as measured by the EQ-5D

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

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

Acronym: PROTection

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Oct 17, 2018
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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