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Clinical Trials/NCT07596407
NCT07596407Not yet recruitingNot Applicable

Long-term Renal and Cardiovascular Prognosis After Severe Acute Renal Failure in Intensive Care : Value of Biomarkers as Risk Stratification Tools

Assistance Publique - Hôpitaux de Paris1 site in 1 country412 target enrollmentStarted: June 1, 2026Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
412
Locations
1
Primary Endpoint
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

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Patients AKIKI2

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

Outcomes

Primary Outcomes

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

Time Frame: 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.

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.

Secondary Outcomes

  • 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.)
  • 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.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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