ntravenous amino acid therapy for kidney protection in cardiac surgery: a multi-centre randomised blinded placebo controlled clinical trial

Intravenous amino acid therapy for kidney protection in cardiac surgery: a multi-centre randomised blinded placebo controlled clinical trial - PROTECTION

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000487-28-IT

Enrollment

3500

Registered

2021-01-07

Start date

2018-08-06

Completion date

Unknown

Last updated

2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing cardiac surgery at risk for developing acute kidney injury MedDRA version: 21.1 Level: PT Classification code 10069339 Term: Acute kidney injury System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Trade Name: ISOPURAMIN - 10 % SOLUZIONE PER INFUSIONE 20 FLACONI 500 ML Product Name: ISOPURAMIN Product Code: [020580155] Pharmaceutical Form: Solution for infusion INN or Proposed INN: AMINOACIDI

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Aged 18 years; Scheduled cardiac surgery; Expected to stay in ICU at least one night after surgery; Signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1750 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1750

Exclusion criteria

Exclusion criteria: 1. Patient currently enrolled into another randomized clinical trial;2. Patient currently receiving or scheduled for intermittent or continuous renal replacement therapy; 3. Patients with CKD of equal or more than CKD stage IV (GFR7 points); 8. Patient has a hypersensitivity (known allergy) to one or more of the included amino acids; 9. Patient has a congenital alteration of amino acid metabolism; 10. Pregnant or currently breastfeeding patients

Design outcomes

Primary

Measure	Time frame
Main Objective: reduce acute kidney injury incidence after cardiac surgery;Secondary Objective: reduce the need and duration of renal replacement therapy, reduce hospital stay and admission to the ICU, reduce overall mortality. Reduce need and duration of mechanical ventilation. Improve quality of life;Primary end point(s): AKI during hospital stay defined by KDIGO stage 1 or greater (serum creatinine increase of at least 1.5 from baseline or >0.3 mg/dl or urine output <0.5 ml/kg/h for 6-12 hours).;Timepoint(s) of evaluation of this end point: During hospital stay	—

Measure

Time frame

Main Objective: reduce acute kidney injury incidence after cardiac surgery;Secondary Objective: reduce the need and duration of renal replacement therapy, reduce hospital stay and admission to the ICU, reduce overall mortality. Reduce need and duration of mechanical ventilation. Improve quality of life;Primary end point(s): AKI during hospital stay defined by KDIGO stage 1 or greater (serum creatinine increase of at least 1.5 from baseline or >0.3 mg/dl or urine output <0.5 ml/kg/h for 6-12 hours).;Timepoint(s) of evaluation of this end point: During hospital stay

—

Secondary

Measure	Time frame
Secondary end point(s): Need and duration of renal replacement therapy, ICU lenght of stay, duration of hospital stay, need and duration of mechanical ventilation, overall mortality, quality of life.;Timepoint(s) of evaluation of this end point: During hospital stay, and at 30, 90 and 180 days from randomization.	—

Countries

Italy

Contacts

Public ContactCRO ALEPH

aleph srl

info@alephsrl.com02700541273

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026