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

Completed

• Conditions: Variceal Hemorrhage; Kidney Injury; Cirrhosis, Liver
• Interventions: Drug: Somatostatin; Drug: Terlipressin; Drug: Octreotide

• Registration Number: NCT03846180
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-15
• Study First Posted: 2019-02-19
• Study Start: 2019-03-01
• Primary Completion: 2019-06-30
• Status Verified: 2019-07
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1682

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Somatostatin/Octreotide group	Somatostatin	Cirrhotic patients with acute gastrointestinal bleeding received somatostatin and/or octreotide without terlipressin.
Somatostatin/Octreotide group	Octreotide	Cirrhotic patients with acute gastrointestinal bleeding received somatostatin and/or octreotide without terlipressin.
Terlipressin group	Terlipressin	Cirrhotic patients with acute gastrointestinal bleeding received terlipressin with or without somatostatin/octreotide.

Primary Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (14)

Department of Gastroenterology, The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Department of Gastroenterology, Air Force Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China

Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University; 🇨🇳 Jinan, Shandong, China

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

Liver Research Center, The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Department of Critical Care Medicine, The Sixth People's Hospital of Shenyang; 🇨🇳 Shenyang, Liaoning, China

Eastern Hepatobiliary Hospital of the Second Military Medical University; 🇨🇳 Shanghai, Shanghai, China

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

Department of Gastroenterology, The First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Department of Gastroenterology, Xi'an Central Hospital; 🇨🇳 Xi'an, Shaanxi, China