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

July 2, 2019 updated by: Xingshun Qi, General Hospital of Shenyang Military Region

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1682

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Center for Liver Cirrhosis, The Fifth Medical Center of PLA General Hospital
      • Beijing, Beijing, China, 100069
        • Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing YouAn Hospital, Capital Medical University
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Liver Research Center, The First Affiliated Hospital of Fujian Medical University
      • Fuzhou, Fujian, China, 350025
        • Department of Hepatobiliary Disease, 900 Hospital of the Joint Logistics Team (formerly called Fuzhou General Hospital)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Department of Gastroenterology, The First Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Department of Gastroenterology, The First Affiliated Hospital of China Medical University
      • Shenyang, Liaoning, China, 110006
        • Department of Critical Care Medicine, The Sixth People's Hospital of Shenyang
      • Shenyang, Liaoning, China, 110042
        • Department of Gastroenterology, Air Force Hospital of Northern Theater Command
      • Shenyang, Liaoning, China, 110840
        • Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Department of Gastroenterology, Xi'an Central Hospital
    • Shandong
      • Jinan, Shandong, China, 250021
        • Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University
    • Shanghai
      • Shanghai, Shanghai, China
        • Eastern Hepatobiliary Hospital of the Second Military Medical University
    • Sichuan
      • Chengdu, Sichuan, China, 610083
        • Department of Gastroenterology, General Hospital of Western Theater Command
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cirrhotic patients with acute gastrointestinal bleeding received terlipressin or somatostatin/octreotide.

Description

Inclusion Criteria:

  1. Cirrhotic patients who were admitted between January 2010 and December 2018.
  2. A diagnosis of acute gastrointestinal bleeding.
  3. Patients who received terlipressin or somatostatin/octreotide.
  4. Age or sex was not limited.
  5. Use of endoscopy was not limited.
  6. Comorbidity was not limited.
  7. Malignancy was not limited.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Terlipressin group
Cirrhotic patients with acute gastrointestinal bleeding received terlipressin with or without somatostatin/octreotide.
Drug: Terlipressin
Continuous or intermittent intravenous infusion of terlipressin was given.
Other Names:
  • Glypressin
Somatostatin/Octreotide group
Cirrhotic patients with acute gastrointestinal bleeding received somatostatin and/or octreotide without terlipressin.
Drug: Somatostatin
Continuous or intermittent intravenous infusion of somatostatin was given.
Other Names:
  • Stilamin
Drug: Octreotide
Continuous or intermittent intravenous infusion of octreotide was given.
Other Names:
  • Sandostatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, an average of 1-2 weeks
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
Through study completion, an average of 1-2 weeks
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
Through study completion, an average of 1-2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Shenyang Military Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 15, 2019

First Posted (Actual)

February 19, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XHNKKY-VASO 2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

This plan to share the individual patient data has been not decided yet.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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