Prospective Multicenter Observational Study of the Management and Prognosis of Severe Acute Kidney Injury (AKI) in Nephrology Units: The French AKI Registry (FAKIR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 750
- 主要终点
- Rate of Complete Renal Recovery at 3 Months After Hospitalization for AKI KDIGO Stage 2 or 3
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
- •Under legal protection (guardianship or trusteeship) without a representative to provide non-opposition
- •Incomplete medical records preventing collection of required baseline data
结局指标
主要结局
Rate of Complete Renal Recovery at 3 Months After Hospitalization for AKI KDIGO Stage 2 or 3
时间窗: Assessed at 3 months (±30 days) after admission for AKI in nephrology ward
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.
次要结局
- All-Cause Mortality at 12 Months After Hospitalization for AKI KDIGO Stage 2 or 3(Assessed at 12 months post-admission (±30 days))
- Incidence of Major Adverse Cardiovascular Events (MACE) at 12 Months(Assessed throughout the 12-month follow-up period)
- Progression to End-Stage Renal Disease (ESRD) at 12 Months(Assessed at 12 months post-AKI hospitalization)