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

NCT ID: NCT03846180

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1682 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2019-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Variceal Hemorrhage Cirrhosis, Liver Kidney Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Terlipressin group

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

Terlipressin

Intervention Type DRUG

Continuous or intermittent intravenous infusion of terlipressin was given.

Somatostatin/Octreotide group

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

Somatostatin

Intervention Type DRUG

Continuous or intermittent intravenous infusion of somatostatin was given.

Octreotide

Intervention Type DRUG

Continuous or intermittent intravenous infusion of octreotide was given.

Interventions

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Terlipressin

Continuous or intermittent intravenous infusion of terlipressin was given.

Intervention Type DRUG

Somatostatin

Continuous or intermittent intravenous infusion of somatostatin was given.

Intervention Type DRUG

Octreotide

Continuous or intermittent intravenous infusion of octreotide was given.

Intervention Type DRUG

Other Intervention Names

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Glypressin Stilamin Sandostatin

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General Hospital of Shenyang Military Region

OTHER

Sponsor Role lead

Responsible Party

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Xingshun Qi

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Beijing, Beijing Municipality, China

Site Status

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

Beijing, Beijing Municipality, China

Site Status

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

Fuzhou, Fujian, China

Site Status

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

Fuzhou, Fujian, China

Site Status

Department of Gastroenterology, The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status

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

Shenyang, Liaoning, China

Site Status

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

Shenyang, Liaoning, China

Site Status

Department of Gastroenterology, Air Force Hospital of Northern Theater Command

Shenyang, Liaoning, China

Site Status

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

Shenyang, Liaoning, China

Site Status

Department of Gastroenterology, Xi'an Central Hospital

Xi'an, Shaanxi, China

Site Status

Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University

Jinan, Shandong, China

Site Status

Eastern Hepatobiliary Hospital of the Second Military Medical University

Shanghai, Shanghai Municipality, China

Site Status

Department of Gastroenterology, General Hospital of Western Theater Command

Chengdu, Sichuan, China

Site Status

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

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 30474439 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30508958 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29996332 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32860184 (View on PubMed)

Other Identifiers

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XHNKKY-VASO 2.0

Identifier Type: -

Identifier Source: org_study_id

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