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Clinical Trials/NCT03846180
NCT03846180
Completed
Not Applicable

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 sites in 1 country1,682 target enrollmentMarch 1, 2019

Overview

Phase
Not Applicable
Intervention
Terlipressin
Conditions
Variceal Hemorrhage
Sponsor
General Hospital of Shenyang Military Region
Enrollment
1682
Locations
14
Primary Endpoint
Incidence of ICA-AKI and kidney function damage in cirrhotic patients with acute gastrointestinal bleeding
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
July 1, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
General Hospital of Shenyang Military Region
Responsible Party
Principal Investigator
Principal Investigator

Xingshun Qi

Principal Investigator

General Hospital of Shenyang Military Region

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

Terlipressin group

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

Intervention: Terlipressin

Somatostatin/Octreotide group

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

Intervention: Somatostatin

Somatostatin/Octreotide group

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

Intervention: Octreotide

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: Through study completion, an average of 1-2 weeks

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

Study Sites (14)

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