DRUG
Terlipressin
Continuous or intermittent intravenous infusion of terlipressin was given.
Terlipressin on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage
Status
Completed
Phase
Not applicable
Enrollment
1,682
Locations
14
Results
Not posted
Publications
4
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Somatostatin
Continuous or intermittent intravenous infusion of somatostatin was given.
DRUG
Octreotide
Continuous or intermittent intravenous infusion of octreotide was given.
Timeline
From registration to results.
First posted
Feb 19, 2019
Study start
Mar 1, 2019
Primary completion
Jun 30, 2019
Study completion
Jul 1, 2019
Results posted
Not reported
Registry updated
Jul 5, 2019
Outcomes
What the study measures.
Primary outcomes
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
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
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
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- Not reported
- Maximum age
- Not reported
- Sex
- ALL
- 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.
Study locations
14 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Center for Liver Cirrhosis, The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, China
Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Liver Research Center, The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Department of Hepatobiliary Disease, 900 Hospital of the Joint Logistics Team (formerly called Fuzhou General Hospital)
Fuzhou, Fujian, China
Department of Gastroenterology, The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Department of Gastroenterology, The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
Department of Critical Care Medicine, The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
Department of Gastroenterology, Air Force Hospital of Northern Theater Command
Shenyang, Liaoning, China
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China
Department of Gastroenterology, Xi'an Central Hospital
Xi'an, Shaanxi, China
Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University
Jinan, Shandong, China
Eastern Hepatobiliary Hospital of the Second Military Medical University
Shanghai, Shanghai Municipality, China
Department of Gastroenterology, General Hospital of Western Theater Command
Chengdu, Sichuan, China
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
Publications
Results and literature.
PMID 30474439 ↗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 30508958 ↗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 29996332 ↗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 32860184 ↗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.
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