NCT03282409进行中（未招募）不适用
Prediction of Chronic Renal Disease After Acute Kidney Injury in the Intensive Care Unit
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 425
- 试验地点
- 1
- 主要终点
- Incidence of chronic kidney disease
研究概览
简要总结
The study aims to develop and validate a prediction score of chronic renal disease occurrence within 3 years after ICU discharge in patients who suffered an acute kidney failure during ICU stay and recovered normal renal function at 90 days following their discharge.
The primary study outcome is the incidence of chronic renal disease within the first 3 years after ICU discharge, defined by a lower glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.
详细描述
As second objectives, the study aims to:
- Evaluate the GFR decline in patients who had an underlying chronic kidney disease.
- Evaluate factors associated with a persistent decreased GFR at day-90.
- Characterization the clinical and biological phenotype of chronic renal disease in these patients.
- Evaluate treatments provided to these patients according to CKD occurence.
- Evaluate the rate of cardiovascular and thrombo-embolic morbidity-mortality.
- Assess the quality of life every year for 3 years.
- Evaluate the medico-economic burden of CKD.
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
- •Patient ⩾ 18 years;
- •Patient suffering an acute kidney injury (defined by AKIN score ⩾1) during ICU stay;
- •Patient discharged alive from the ICU;
- •Patient's signed consent obtained;
- •Patient covered by a healthcare insurance.
排除标准
- •Pregnant or breastfeeding woman;
- •SOFA score < 1 (except for kidney assessment) at time of ICU admission;
- •End-stage of renal failure or dialysis treatment or renal transplantation prior to ICU admission;
- •Patient treated with dialysis at ICU discharge;
- •Immunosuppressive treatment prior to ICU admission;
- •Patient under legal incapacity (tutor or guardian protection);
- •Being unable to follow-up of the study;
- •Life expectancy expected shorter than 90 days;
- •Refusal to participate in the study;
- •Patient's main address is outside of Il de France region for the centers in this region;
- •Patient < 18 years;
- •Patient not affiliated to national social security scheme;
- •Patient deprived of liberty by judicial measure.
结局指标
主要结局
Incidence of chronic kidney disease
时间窗: At 3 years
Incidence of chronic kidney disease defined by a decreased glomerular filtration rate (GFR) under 60 mL/minute/1.73m2.
次要结局
- Progression of chronic renal disease defined by the slope of GFR decline(At 3 years)
- All-cause mortality(At 3 years)
- Progression of chronic renal disease defined by the number of patients with end-stage renal disease requiring dialysis or renal transplantation(At 3 years)
- Quality of life assessment(At the end of 1 year)
- Cost(At 3 years)
- Progression of the proteinuria(At 3 years)
- Occurrence of cardiovascular events and thromboembolic events(At 3 years)
研究者
研究点 (1)
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