Renal Injury, Acute
Conditions
Keywords
cardiovascular events, renal events, chronic renal failure, dialysis
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.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (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 |
| 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. | 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 |
| 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. | 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) |
Countries
France
Contacts
CONTACTKhalil CHAIBI, Dr
Outcome results
None listed