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

NCT07596407 | Not Yet Recruiting

• 1 other identifier: APHP251915
• Study Type: observational
• Target: 412
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cardiovascular events; renal events; chronic renal failure; dialysis

Outcome Measures

Primary Outcomes (1)

• Occurrence, between 60 days after inclusion in the AKIKI 2 study and the date of the last news, of a composite cardio-renal criteria defined by the occurrence of a MACE and/or a MAKE criteria or death from all causes, the first event being retained

  Composite criteria : occurrence, between day 60 (60 days after inclusion in the AKIKI 2 study) and the date of the last news, of a cardio-renal composite criteria defined by the occurrence of a major cardiovascular event (myocardial infarction, stroke, hospitalization for heart failure) and/or a major renal event (dependence on chronic dialysis, progression to severe chronic renal failure) or death from all causes, the first event being retained.

  Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.

Secondary Outcomes (3)

• Occurrence, between day 60 and the date of the latest news, of a MAKE criteria, the first event being retained

  Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.

• Occurrence, between day 60 and the date of the latest news, of a MACE criteria, the first event being retained

  Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.

• Diagnosis between day 60 and the date of the last news of a heart failure diagnosed in town via echocardiography

  Data will be collected from patients included between May 7, 2018 and October 11, 2019 as part of the AKIKI 2 study, between day 60 after their inclusion until the date of the last news.

Study Arms (1)

Patients AKIKI2

The study population will include patients from the AKIKI 2 trial who are alive at day 60.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population comes from the AKIKI-2 cohort, which included adult patients (≥18 years) in intensive care, under mechanical ventilation and/or catecholamines, presenting severe acute renal failure (KDIGO 3) complicated by oligo-anuria ≥72 h or uremia between 40 and 50 mmol/L. For the present study, the eligible population is defined among patients surviving to day 60 since their inclusion, 412 subjects out of the 757 initially included. Of these 412 subjects, 214 recovered spontaneously during the observational phase, 57 had an EER initiated during the observational phase, and 141 participated in the randomized phase.

You may not qualify if:

• Patients opposed to their participation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Réanimation médico-chirurgicale, Hôpital Avicenne

Bobigny, France

Location

MeSH Terms

Conditions

Acute Kidney Injury; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Khalil CHAIBI, Dr

CONTACT

00 33 1 48 95 52 41; khalil.chaibi@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

FR (1)