NCT07596407Not yet recruiting
Acute Kidney Injury : Long-term Renal and Cardiovascular Prognosis and Biomarker-based Risk Assessment
Long-term Renal and Cardiovascular Prognosis After Severe Acute Renal Failure in Intensive Care : Value of Biomarkers as Risk Stratification Tools
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 412 (estimated)
- First submitted
- 13 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 30 May 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Chronic kidney disease
- NCT number
- NCT07596407
What you commit to
- Study type: Observational
- Planned participants: 412
- From 1 Jun 2026 to the primary completion date, 30 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients opposed to their participation
Who the study is looking for
- The study population concerns patients included in the AKIKI 2 study who survive 60 days after inclusion in the AKIKI 2 study.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Réanimation médico-chirurgicale, Hôpital Avicenne Coordinator of this site? Confirm its status | Bobigny | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.