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

Sponsor
General Hospital of Shenyang Military Region (Other)
Overall Status
Completed
CT.gov ID
NCT03846180
Collaborator
(none)
1,682
14
4
120.1
30

Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
1682 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Terlipressin Versus Somatostatin/Octreotide on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage (TORCH): A Retrospective Multicenter Observational Study
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Jun 30, 2019
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Incidence of ICA-AKI and kidney function damage in cirrhotic patients with acute gastrointestinal bleeding [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 [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 [Through study completion, an average of 1-2 weeks]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Liver Cirrhosis, The Fifth Medical Center of PLA General Hospital Beijing Beijing China 100039
    2 Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing YouAn Hospital, Capital Medical University Beijing Beijing China 100069
    3 Liver Research Center, The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China 350005
    4 Department of Hepatobiliary Disease, 900 Hospital of the Joint Logistics Team (formerly called Fuzhou General Hospital) Fuzhou Fujian China 350025
    5 Department of Gastroenterology, The First Affiliated Hospital of Nanchang University Nanchang Jiangxi China 330006
    6 Department of Gastroenterology, The First Affiliated Hospital of China Medical University Shenyang Liaoning China 110001
    7 Department of Critical Care Medicine, The Sixth People's Hospital of Shenyang Shenyang Liaoning China 110006
    8 Department of Gastroenterology, Air Force Hospital of Northern Theater Command Shenyang Liaoning China 110042
    9 Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area) Shenyang Liaoning China 110840
    10 Department of Gastroenterology, Xi'an Central Hospital Xi'an Shaanxi China 710000
    11 Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University Jinan Shandong China 250021
    12 Eastern Hepatobiliary Hospital of the Second Military Medical University Shanghai Shanghai China
    13 Department of Gastroenterology, General Hospital of Western Theater Command Chengdu Sichuan China 610083
    14 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 Hangzhou Zhejiang China 310003

    Sponsors and Collaborators

    • General Hospital of Shenyang Military Region

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Xingshun Qi, Principal Investigator, General Hospital of Shenyang Military Region
    ClinicalTrials.gov Identifier:
    NCT03846180
    Other Study ID Numbers:
    • XHNKKY-VASO 2.0
    First Posted:
    Feb 19, 2019
    Last Update Posted:
    Jul 5, 2019
    Last Verified:
    Jul 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 5, 2019