An observational study in Renal Injury, Acute, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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:
Secondary objectives include :
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.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's planned enrollment of 412 is above the median of 150 across 773 observational studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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
The study population will include patients from the AKIKI 2 trial who are alive at day 60.
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.
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.
Occurrence, between day 60 and the date of the latest news, of a MAKE criteria, the first event being retained
Occurrence, between day 60 (after inclusion in the AKIKI 2 study) and the date of the last news, of a MAKE criteria defined by dependence on chronic dialysis or by progression towards severe chronic renal failure (stage 4 or 5 KDIGO), 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.
Occurrence, between day 60 and the date of the latest news, of a MACE criteria, the first event being retained
Occurrence, between day 60 (after inclusion in the AKIKI 2 study) and the date of the last news, of a MACE criteria defined by a myocardial infarction or a stroke or hospitalization for heart failure, 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.
Diagnosis between day 60 and the date of the last news of a heart failure diagnosed in town via echocardiography
The diagnosis of heart failure will be established in the event of compatible clinical symptoms (dyspnea, congestive signs) with ultrasound : * impaired LVEF under 40 % * a moderately impaired LVEF, between 41 and 49% * a preserved LVEF more than 50% associated with structural abnormalities (left ventricular hypertrophy, left atrial dilatation) and/or functional (elevation of left ventricular filling pressures and/or PAPs estimated \> 35 mmHg or a Vmax \> 2.8 m/s) in a context of increased natriuretic peptides (BNP \> 35 ng/L or NT-proBNP \> 125 ng/L)
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.
Plan to share: Undecided
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris