About this trial
Acute Kidney Injury (AKI) is a common and serious condition in hospitalized patients, especially when it reaches stages 2 or 3 according to the KDIGO classification. These severe forms are associated with high mortality, a risk of progression to chronic kidney disease (CKD), and frequent cardiovascular complications. However, current data on how nephrologists manage these patients during hospitalization-and how these practices influence long-term outcomes-are limited and heterogeneous.
The FAKIR study (French AKI Registry) is a prospective, multicenter, non-interventional observational study designed to describe the clinical management of patients admitted to nephrology departments for AKI stage 2 or 3 and to assess their renal and cardiovascular outcomes up to one year. The study hypothesizes that better characterization of in-hospital practices and patient trajectories will help identify predictors of renal recovery, progression to end-stage renal disease, and major cardiovascular events.
Patients will be followed during hospitalization and at 3, 6, and 12 months to assess renal function, mortality, cardiovascular events, and rehospitalizations. This registry aims to provide real-life, multicenter data to support future guidelines and the development of structured post-AKI care pathways.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years at admission
Hospitalized in a nephrology ward (standard or intensive nephrology care unit)
Diagnosis of acute kidney injury (AKI) stage 2 or 3 according to KDIGO criteria at the time of admission
Availability of follow-up data at 3 months (clinical or laboratory)
Disqualifiers
AKI stage 1 only
AKI acquired outside the nephrology department without subsequent transfer to nephrology
Hospitalized for another reason without documented AKI stage 2 or 3
Refusal or opposition to data reuse for research purposes
Trial population
The study population consists of adult patients (≥18 years) hospitalized in nephrology departments across multiple French university hospitals for acute kidney injury (AKI) stage 2 or 3. Patients are identified prospectively at the time of admission to nephrology units, either directly or via transfer from emergency or other hospital departments. Only patients with confirmed KDIGO stage 2 or 3 AKI at admission are included. Data are collected during hospitalization and up to 12 months post-discharge to assess renal and cardiovascular outcomes.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Rate of Complete Renal Recovery at 3 Months After Hospitalization for AKI KDIGO Stage 2 or 3
Renal recovery is defined as a return of serum creatinine to ≤125% of the patient's baseline (pre-AKI) value, estimated using the CKD-EPI formula. Creatinine values are collected from medical records or follow-up labs performed at 3 months post-discharge. This outcome reflects the extent of renal function recovery following hospitalization for severe AKI and helps identify prognostic factors associated with favorable evolution.
Secondary outcomes
All-Cause Mortality at 12 Months After Hospitalization for AKI KDIGO Stage 2 or 3
All-cause mortality is defined as the proportion of patients who die from any cause within 12 months following their admission for AKI KDIGO stage 2 or 3. Vital status is obtained from hospital records, follow-up contact, or national registries. This outcome will allow assessment of medium-term prognosis and identification of clinical factors associated with mortality in patients with severe AKI managed in nephrology units.
Incidence of Major Adverse Cardiovascular Events (MACE) at 12 Months
MACE includes non-fatal myocardial infarction, non-fatal stroke, hospitalization for acute heart failure, and cardiovascular death. Events will be identified from medical records, discharge summaries, and follow-up contacts. This outcome will assess the cardiovascular burden among patients with severe AKI managed in nephrology settings, and help determine the link between in-hospital management strategies and long-term cardiovascular risk.
Progression to End-Stage Renal Disease (ESRD) at 12 Months
ESRD is defined as the initiation of chronic renal replacement therapy (dialysis or kidney transplantation) or a sustained eGFR \<15 mL/min/1.73m². Data are collected through follow-up visits, patient contact, or hospital records. This measure evaluates long-term renal outcomes and identifies risk factors for irreversible kidney failure following AKI KDIGO stage 2 or 3.
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Sponsors and contacts
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