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

Cirrhosis, Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846180
• Other study ID #: XHNKKY-VASO 2.0
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: July 2019
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1682
• Est. completion date: July 1, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Gastrointestinal Hemorrhage
• Hemorrhage
• Kidney Injury
• Liver Cirrhosis
• Variceal Hemorrhage

Intervention

Drug:
• Terlipressin
Continuous or intermittent intravenous infusion of terlipressin was given.
• Somatostatin
Continuous or intermittent intravenous infusion of somatostatin was given.
• Octreotide
Continuous or intermittent intravenous infusion of octreotide was given.

Locations

Country	Name	City	State
China	Center for Liver Cirrhosis, The Fifth Medical Center of PLA General Hospital	Beijing	Beijing
China	Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing YouAn Hospital, Capital Medical University	Beijing	Beijing
China	Department of Gastroenterology, General Hospital of Western Theater Command	Chengdu	Sichuan
China	Department of Hepatobiliary Disease, 900 Hospital of the Joint Logistics Team (formerly called Fuzhou General Hospital)	Fuzhou	Fujian
China	Liver Research Center, The First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian
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	Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University	Jinan	Shandong
China	Department of Gastroenterology, The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Eastern Hepatobiliary Hospital of the Second Military Medical University	Shanghai	Shanghai
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, The First Affiliated Hospital of China Medical University	Shenyang	Liaoning
China	Department of Gastroenterology, Xi'an Central Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

References & Publications (3)

Zhang J, Rössle 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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