Prospective Multicenter Study to Assess the Predictive Value of PIIINP and Urinary NGAL in Renal Function Recovery During Acute Tubular Necrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 287
- 试验地点
- 1
- 主要终点
- PIIINP/Urinary Creatinine ratio levels between patients experimenting CRF or not.
研究概览
简要总结
Acute Renal Failure (ARF) is defined by a severe, and usually reversible, glomerular filtration rate decreasing. Acute Tubular Necrosis (ATN) remain the major cause of ARF involving distress and destruction of tubular cells. This specific typology of ARF may evolve toward Chronic Renal Failure (CRF) concretizing a major public health issue.
Predict the progression of ARF towards CRF appears essential. The investigators believe that the PIIINP and urinary NGAL biomarkers may constitute robust biomarkers of progression risk towards CRF.
详细描述
Acute Renal Failure (ARF) is defined by a severe, and usually reversible, glomerular filtration rate decreasing. Beside its frequency, ARF may be associated with severe prognostic. Thus, patient admitted in ICU and suffering of ARF requiring dialysis, had a higher risk of mortality up to 50%.
Tubulointerstitial nephropathies, particularly Acute Tubular Necrosis (ATN) remain the major cause of ARF, representing 45-50% of cases. The ATN is due to suffering and destruction of tubular cells which are very sensitive to ischemia-reperfusion lesions because tubular reabsorption functions require significant and constant energy intake. However, ATN represents a relatively homogeneous group in terms of acute kidney disease typology. Homogeneity and significant frequency compels ATN as an optimal model to study function recovery after ARF.
ARF constitutes a major public health issue. Actually, incidence of Chronic Renal Failure (CRF) after an ARF, due to ATN, is estimated between 19% and 31%. In addition 12.5% of patients with specific ARF presentation immediately reach End-stage Renal Disease (ESRD), and the occurrence of ARF requiring dialysis, triples the risk of chronic renal support.
Therefore, predict the progression of ARF towards CRF appears essential.
At this time, the investigators currently lack of reliable biomarkers to predict such progression. This pejorative kidney development is due to the persistence of intrarenal inflammation, rapid development of interstitial fibrosis and deficiency in tubular restoration. It involves complex mechanisms of inflammatory response, and vascular and tubular remodeling.
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
- •off-age patient.
- •ATN diagnosis based on 1) typical clinical environment (sepsis, nephrotoxicity...) 2) 50% decrease of glomerular filtration flow (according clearance MDRD) or more than 100micromol plasmatic creatinine increase. 3) no renal function improvement after efficient vascular filling (>750cc normal saline or equivalent).
排除标准
- •ARF not related with ATN context.
- •Life expectancy less than 3 months.
- •Protocol refusal
结局指标
主要结局
PIIINP/Urinary Creatinine ratio levels between patients experimenting CRF or not.
时间窗: 12months after initial diagnosis.
We expect to highlight different ratio PIIINP/Urinary Creatinine levels and evolution between patients experimenting CRF or not (defined less than 60 mL/min according MDRD formula).
次要结局
- NGAL/Urinary Creatinine ratio levels between patients experimenting CRF or not.(12, 18 and 24 months after initial diagnosis.)
- Correlation between NGAL/Urinary Creatinine and PIIINP/Urinary Creatinine ratios among patients with ARF.(3, 6, 12, 18 or 24 months after initial diagnosis.)
- Validation of high diagnostic performance of NGAL/Urinary Creatinine ratio to predict CRF occurrence.(3, 6, 12, 18 or 24 months after initial diagnosis.)
- Validation of high diagnostic performance of PIIINP/Urinary Creatinine to predict CRF occurrence.(3, 6, 12, 18 or 24 months after initial diagnosis.)