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临床试验/NCT04184934
NCT04184934Unknown不适用

Optimal Clinical Predictors to Acute Kidney Injury in Cirrhotic Patients Experienced Acute Gastrointestinal Hemorrhage

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
Mortality

研究概览

简要总结

Acute kidney injury (AKI) is a common complication, occurring in approximately 20% of hospitalized cirrhotic patients and has a significant negative impact on patients' outcomes according to either the initial stage (at the time of the first fulfillment of AKI criteria), or the peak stage (at the peak value of serum creatinine concentration during hospitalization). Among all the precipitating factors to cirrhotic AKI, acute gastrointestinal hemorrhage is a common cause that leads to a decrease in effective arterial blood volume in the hyperdynamic circulatory status of cirrhosis. However, there is still lack of optimal predictors to developing AKI in cirrhotic patients suffering from acute GI bleeding. A number of biomarkers associated with AKI were recently described. Some studies have shown that these novel biomarkers increase with the severity of liver injury and are predictive of clinical outcomes. However, the effective prediction, definitive diagnosis and differentiation of AKI by these biomarkers are still controversial. Furthermore, there is no clinical studies focus on the applicability and potential alteration in the setting of acute gastrointestinal hemorrhage in patients with cirrhosis. Aim and significance: In this study, we aim to investigate the capability of novel renal biomarkers in predicting development of acute kidney injury, differentiating causes (between pre-renal AKI, acute tubular necrosis, and hepatorenal syndrome), and predicting the response to renal treatment as well as the hepatic and overall outcomes in patients with cirrhosis suffering from acute gastrointestinal hemorrhage.

详细描述

Specific aims of this study :

  1. To examine the influences of acute gastrointestinal hemorrhage on the serological or urinary level of novel renal biomarkers in patients with cirrhosis.
  2. To investigate the ability of novel biomarkers to predict the development of acute kidney injury and the response to renal salvage treatment in patients with cirrhosis suffering from acute gastrointestinal hemorrhage.
  3. To investigate the ability of novel biomarkers to differentiate the precipitating factors (such as sepsis-induced AKI, hypervolemia-induced AKI, etc.) and the causes of AKI between pre-renal AKI, acute tubular necrosis, and hepatorenal syndrome.
  4. To investigate the ability of these novel biomarkers to predict the hepatic and overall outcomes in patients with cirrhosis suffering from acute gastrointestinal hemorrhage.

Estimation of sample size :

According to previous studies, the estimated incidence of AKI in cirrhotic patients suffering from gastrointestinal hemorrhage is about 10-15%. The type 1 error is set as 0.05; and the type 2 error is set as 0.2. Then, the calculated sample size is about 80. Considering the possibility of loss of follow-up is about 10%, the estimated sample size will be about 90 patients.

Sample collection and laboratory experiments:

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
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consecutive adult cirrhotic patients admitted to Taipei Veterans General Hospital for suffering from acute gastrointestinal hemorrhage without intervention within 3 days

排除标准

  • Patients less than 20 years old.
  • Patients with antecedent or ongoing active malignancy.
  • Patients with human immunodeficiency virus coinfection or severe comorbidities, such as end-stage renal disease or uremia without regular dialysis, recent acute coronary syndrome or stroke, severe heart failure, severe arrhythmia, and major trauma.
  • Patients with severe hyperbilirubinemia with total bilirubin > 10mg/dL.
  • Patients who underwent trans-jugular intrahepatic portosystemic shunt.
  • Patients who are pregnant or breastfeeding.
  • Patients who refuse to join the study.

结局指标

主要结局

Mortality

时间窗: 6 weeks

Inpatient mortality rate

Incidence rates of AKI

时间窗: 6 weeks

Incidence rates of AKI in patient suffering from acute gastrointestinal hemorrhage

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

vghtpe user

Taipei Veterans General Hospital

Taipei Veterans General Hospital, Taiwan

研究点 (1)

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