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OpenTrials
Completed

NCT Number: NCT03846180

Terlipressin on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for Liver Cirrhosis, The Fifth Medical Center of PLA General Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cirrhotic patients who were admitted between January 2010 and December 2018.
  • 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.

Treatment and study plan

Terlipressin

Drug

Continuous or intermittent intravenous infusion of terlipressin was given.

Other names: Glypressin

Somatostatin

Drug

Continuous or intermittent intravenous infusion of somatostatin was given.

Other names: Stilamin

Octreotide

Drug

Continuous or intermittent intravenous infusion of octreotide was given.

Other names: Sandostatin

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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