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

NCT03846180 | Completed

• 1 other identifier: XHNKKY-VASO 2.0
• Study Type: observational
• Target: 1,682
• Locations: 1 country
• Sites: 14

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.

Conditions

Variceal Hemorrhage; Cirrhosis, Liver; Kidney Injury

Outcome Measures

Primary Outcomes (3)

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

  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

  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

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

  Through study completion, an average of 1-2 weeks

Study Arms (2)

Terlipressin group

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

Drug: Terlipressin

Somatostatin/Octreotide group

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

Drug: Somatostatin; Drug: Octreotide

Interventions

Terlipressin DRUG

Continuous or intermittent intravenous infusion of terlipressin was given.

Also known as: Glypressin

Terlipressin group

Somatostatin DRUG

Continuous or intermittent intravenous infusion of somatostatin was given.

Also known as: Stilamin

Somatostatin/Octreotide group

Octreotide DRUG

Continuous or intermittent intravenous infusion of octreotide was given.

Also known as: Sandostatin

Somatostatin/Octreotide group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (14)

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

Beijing, Beijing Municipality, 100039, China

Location

Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

Liver Research Center, The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

Department of Hepatobiliary Disease, 900 Hospital of the Joint Logistics Team (formerly called Fuzhou General Hospital)

Fuzhou, Fujian, 350025, China

Location

Department of Gastroenterology, The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

Department of Gastroenterology, The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Department of Critical Care Medicine, The Sixth People's Hospital of Shenyang

Shenyang, Liaoning, 110006, China

Location

Department of Gastroenterology, Air Force Hospital of Northern Theater Command

Shenyang, Liaoning, 110042, China

Location

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, 110840, China

Location

Department of Gastroenterology, Xi'an Central Hospital

Xi'an, Shaanxi, 710000, China

Location

Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University

Jinan, Shandong, 250021, China

Location

Eastern Hepatobiliary Hospital of the Second Military Medical University

Shanghai, Shanghai Municipality, China

Location

Department of Gastroenterology, General Hospital of Western Theater Command

Chengdu, Sichuan, 610083, China

Location

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, 310003, China

Location

Related Publications (4)

• Zhang J, Rossle M, Zhou X, Deng J, Liu L, Qi X. Terlipressin for the treatment of hepatorenal syndrome: an overview of current evidence. Curr Med Res Opin. 2019 May;35(5):859-868. doi: 10.1080/03007995.2018.1552575. Epub 2019 Jan 4.

  PMID: 30474439 BACKGROUND

• Zhou X, Tripathi D, Song T, Shao L, Han B, Zhu J, Han D, Liu F, Qi X. Terlipressin for the treatment of acute variceal bleeding: A systematic review and meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Nov;97(48):e13437. doi: 10.1097/MD.0000000000013437.

  PMID: 30508958 BACKGROUND

• Zhou XM, Qi XS, Jia JD. [An evidence-based terlipressin therapy for gastroesophageal variceal hemorrhage]. Zhonghua Gan Zang Bing Za Zhi. 2018 Apr 20;26(4):245-248. doi: 10.3760/cma.j.issn.1007-3418.2018.04.002. Chinese.

  PMID: 29996332 BACKGROUND

• Xu X, Liu B, Lin S, Li B, Wu Y, Li Y, Zhu Q, Yang Y, Tang S, Meng F, Chen Y, Yuan S, Shao L, Bernardi M, Yoshida EM, Qi X. Terlipressin May Decrease In-Hospital Mortality of Cirrhotic Patients with Acute Gastrointestinal Bleeding and Renal Dysfunction: A Retrospective Multicenter Observational Study. Adv Ther. 2020 Oct;37(10):4396-4413. doi: 10.1007/s12325-020-01466-z. Epub 2020 Aug 28.

  PMID: 32860184 DERIVED

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Terlipressin; Somatostatin; Octreotide

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Pituitary Hormone Release Inhibiting Hormones; Hypothalamic Hormones; Pancreatic Hormones; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 19, 2019
• Study Start: March 1, 2019
• Primary Completion: June 30, 2019
• Study Completion: July 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

CN (14)