Acute Kidney Injury : Long-term Renal and Cardiovascular Prognosis and Biomarker-based Risk Assessment (AKIRA)

Assistance Publique - Hôpitaux de Paris

Status

Not yet enrolling

Conditions

Renal Injury, Acute

Study type

Observational

Funder types

Other

Identifiers

NCT07596407

APHP251915

Details and patient eligibility

About

Patients who develop severe acute kidney injury (AKI) in intensive care remain at increased long-term risk of mortality, major cardiovascular events, and chronic renal complications, including prolonged dependence on renal replacement therapy. These adverse outcomes are thought to result from persistent inflammation, fibrosis, and cardio-renal interactions, which are not adequately captured by conventional clinical or biological markers.

This study is an ancillary analysis of the AKIKI 2 trial. The main objective is to assess whether biomarkers of inflammation and fibrosis, specifically galectin-3 (Gal-3) and CD146, measured during the acute phase of AKI, can predict and stratify long-term cardio-renal risk in patients who survived to day 60 after severe AKI in the ICU.

The primary endpoint is the occurrence, between day 60 and the last follow-up, of a composite cardio-renal outcome, defined as the first occurrence of:

a major cardiovascular event (myocardial infarction, stroke, or hospitalization for heart failure),
a major renal event (chronic dialysis dependence or progression to severe chronic kidney disease),
or death from any cause.

Secondary objectives include :

describing the long-term incidence of major renal events (MAKE),
describing the incidence of major cardiovascular events (MACE),
evaluating the predictive ability of Gal-3 and CD146 for the occurrence of MAKE,
evaluating their ability to predict long-term MACE and deterioration of cardiovascular function.

The study population will include patients from the AKIKI 2 trial who are alive at day 60. Follow-up data (creatinine levels, dialysis dependence, cardiovascular events, etc.) will be collected through telephone interviews with patients and their referring physicians. When appropriate, a cardiology referral will be recommended as part of routine clinical care.

Enrollment

412 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

The study population concerns patients included in the AKIKI 2 study who survive 60 days after inclusion in the AKIKI 2 study.

Exclusion criteria

Patients opposed to their participation