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

NCT07596407 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 412

Last updated 2026-05-19

No results posted yet for this study

Summary

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.

Conditions

  • Renal Injury, Acute

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-05-30
Completion
2027-05-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07596407 on ClinicalTrials.gov