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临床试验/NCT03846180
NCT03846180已完成不适用

Terlipressin Versus Somatostatin/Octreotide on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage (TORCH): A Retrospective Multicenter Observational Study

General Hospital of Shenyang Military Region14 个研究点 分布在 1 个国家目标入组 1,682 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,682
试验地点
14
主要终点
Incidence of ICA-AKI and kidney function damage in cirrhotic patients with acute gastrointestinal bleeding

研究概览

简要总结

Terlipressin and somatostatin/octreotide are the first-line choices for the treatment of acute variceal bleeding in liver cirrhosis. Acute kidney injury can develop in patients presenting with acute variceal bleeding. On the other hand, evidence suggests that terlipressin can reverse hepatorenal syndrome. It has been hypothesized that terlipressin can protect the renal function in cirrhotic patients with acute variceal bleeding, except for control of bleeding.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Cirrhotic patients who were admitted between January 2010 and December
  • A diagnosis of acute gastrointestinal bleeding.
  • Patients who received terlipressin or somatostatin/octreotide.
  • Age or sex was not limited.
  • Use of endoscopy was not limited.
  • Comorbidity was not limited.
  • Malignancy was not limited.

排除标准

  • Renal parenchymal diseases.
  • Absence of baseline serum creatinine.
  • Absence of serum creatinine 3-5 days after terlipressin or somatostatin/octreotide.
  • Duration of terlipressin or somatostatin/octreotide was less 3 days.
  • Patients who underwent transjugular intrahepatic portosystemic shunt.
  • Patients who underwent surgical shunt, splenectomy with or without devascularization, or liver transplantation.

研究组 & 干预措施

Terlipressin group

Cirrhotic patients with acute gastrointestinal bleeding received terlipressin with or without somatostatin/octreotide.

干预措施: Terlipressin (Drug)

Somatostatin/Octreotide group

Cirrhotic patients with acute gastrointestinal bleeding received somatostatin and/or octreotide without terlipressin.

干预措施: Somatostatin (Drug)

Somatostatin/Octreotide group

Cirrhotic patients with acute gastrointestinal bleeding received somatostatin and/or octreotide without terlipressin.

干预措施: Octreotide (Drug)

结局指标

主要结局

Incidence of ICA-AKI and kidney function damage in cirrhotic patients with acute gastrointestinal bleeding

时间窗: Through study completion, an average of 1-2 weeks

ICA-AKI and kidney function damage

Effect of ICA-AKI and kidney function damage on in-hospital mortality of cirrhotic patients with acute gastrointestinal bleeding

时间窗: Through study completion, an average of 1-2 weeks

In-hospital mortality

Effect of terlipressin on the in-hospital mortality of cirrhotic patients with acute gastrointestinal bleeding with ICA-AKI and kidney function damage

时间窗: Through study completion, an average of 1-2 weeks

In-hospital mortality associated with ICA-AKI and kidney function damage

次要结局

未报告次要终点

研究者

发起方
General Hospital of Shenyang Military Region
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xingshun Qi

Principal Investigator

General Hospital of Shenyang Military Region

研究点 (14)

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