Urinary Biomarker NGAL in Decompensated Cirrhosis: Early Prediction of AKI and of Treatment Response
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Accuracy of NGAL to predict no response to albumin expansion
研究概览
简要总结
The purpose of this study is to test the accuracy of urinary neutrophil-gelatinase associated lipocalin (NGAL) and other biomarkers (plasma renin, norepinephrine) to predict acute kidney injury (AKI) development in patients with cirrhosis and bacterial infection and to predict response to AKI treatment with albumin and albumin with terlipressin in patients with suspected hepatorenal syndrome.
研究设计
- 研究类型
- Observational
- 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
- •Cirrhosis diagnosis by liver biopsy or combination of clinical, laboratorial, endoscopic and imagenological data;
- •Presence of ascites and/or hepatic hydrothorax;
- •Age over 18 years old;
- •Diagnosis of bacterial infection (including spontaneous bacterial peritonitis and others) with or without acute kidney injury (defined as a serum creatinine above 1.5mg/dL at admission) or acute kidney injury without bacterial infection;
- •Agreement to participate in the study, registered by informed consent;
排除标准
- •Serious comorbidities (functional class IV heart failure, O2 dependent chronic obstructive pulmonary disease, advanced cancer);
- •Shock, as defined by American College of Chest Physicians;
- •Chronic kidney disease with serum creatinine persistently above 1.5mg/dL in the previous 6 months and/or with sonographic findings of chronic nephropathy;
- •Intrinsic nephropathy with hematuria over 50 red cells/high power field and dysmorphic erythrocyte and/or proteinuria over 500mg/24h;
- •Use of nephrotoxic drugs in the previous 30 days;
- •Dialysis prior to study inclusion;
- •Previous solid organ transplantation.
结局指标
主要结局
Accuracy of NGAL to predict no response to albumin expansion
时间窗: One day after albumin expansion (day 3)
We will build a receiver-operating curve and calculate the area under the curve to determine the accuracy of NGAL to predict no response to albumin expansion. No response will be defined as an absence of a drop of serum creatinine to a final value below 1.5mg/dL in the day after the end of albumin expansion. Albumin will be administrated as International Ascites Club recommendations, i.e. in the dose of 1g/kg/day for 2 days in patients with suspected hepatorenal syndrome.
次要结局
- Predictors of mortality(In-hospital, 30 days and 90 days)
- Accuracy of urinary NGAL and other biomarkers to predict no response to hepatorenal syndrome treatment(Treatment period (maximum of 14 days))
- Accuracy of urinary NGAL and other biomarkers to predict development and progression of acute kidney injury (AKI) in patients with bacterial infection(During antibiotic therapy and during hospital stay)
- Urinary NGAL as a predictor of adverse events of AKI treatment in cirrhosis(During treatment period)
- Accuracy of other biomarkers to predict no response to albumin expansion(One day after albumin expansion (day 3))
研究者
Alberto Queiroz Farias
Associate Professor of Medicine School of University of Sao Paulo
University of Sao Paulo