Predictive Value of PIIINP and Urinary NGAL in Renal Function Recovery (PIIINP-NGAL)
Prospective Multicenter Study to Assess the Predictive Value of PIIINP and Urinary NGAL in Renal Function Recovery During Acute Tubular Necrosis
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.
研究概览
详细说明
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.
Two promising biomarkers of renal fibrosis, ARF occurrence and CRF progression risk appear in recent years: the Procollagen III N-terminal peptide (PIIINP) and the neutrophil gelatinase associated lipocalin (NGAL). The investigators believe that the PIIINP and urinary NGAL may constitute robust biomarkers of progression (or not) towards CRF in ARF context. Firstly, PIIINP is a good reflection of fibrosis process inside the kidney. Secondarily, NGAL is a marker of renal tubule remodeling after renal aggression. The combination of these two biomarkers could therefore efficiently reflect the balance tubular fibrosis/restoration and may allow optimal prediction of renal function recovery.
The investigators hypothesize that these two biomarkers may be used to assess the risk of CRF progression during ARF in ATN context.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Nantes、法国、44093
- CHU de Nantes
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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).
- Consent.
Exclusion Criteria:
- ARF not related with ATN context.
- Life expectancy less than 3 months.
- Protocol refusal
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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PIIINP/Urinary Creatinine ratio levels between patients experimenting CRF or not.
大体时间:12months after initial diagnosis.
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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).
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12months after initial diagnosis.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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NGAL/Urinary Creatinine ratio levels between patients experimenting CRF or not.
大体时间:12, 18 and 24 months after initial diagnosis.
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We expect to highlight different ratio NGAL/Urinary Creatinine levels and evolution between patients experimenting CRF or not (defined less than 60 mL/min according MDRD formula).
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12, 18 and 24 months after initial diagnosis.
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Correlation between NGAL/Urinary Creatinine and PIIINP/Urinary Creatinine ratios among patients with ARF.
大体时间:3, 6, 12, 18 or 24 months after initial diagnosis.
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We expect to highlight linear correlation between NGAL/Urinary Creatinine and PIIINP/Urinary Creatinine ratios among patients with ARF.
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3, 6, 12, 18 or 24 months after initial diagnosis.
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Validation of high diagnostic performance of NGAL/Urinary Creatinine ratio to predict CRF occurrence.
大体时间:3, 6, 12, 18 or 24 months after initial diagnosis.
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Sensitivity of NGAL/Urinary Creatinine ratio will be assessed at each time frame.
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3, 6, 12, 18 or 24 months after initial diagnosis.
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Validation of high diagnostic performance of PIIINP/Urinary Creatinine to predict CRF occurrence.
大体时间:3, 6, 12, 18 or 24 months after initial diagnosis.
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Sensitivity of PIIINP/Urinary Creatinine ratio will be assessed at each time frame.
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3, 6, 12, 18 or 24 months after initial diagnosis.
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PROG/11/59
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