Clinical trial NCT03846180: Terlipressin on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage
Official title: Terlipressin Versus Somatostatin/Octreotide on Effect of Renal Function in Cirrhotic Patients With Acute Gastrointestinal Hemorrhage (TORCH): A Retrospective Multicenter Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Variceal Hemorrhage
Cirrhosis, Liver
Kidney Injury
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 1682
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cirrhotic patients with acute gastrointestinal bleeding received terlipressin or somatostatin/octreotide.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of ICA-AKI and kidney function damage in cirrhotic patients with acute gastrointestinal bleeding
timeFrame: Through study completion, an average of 1-2 weeks
measure: Effect of ICA-AKI and kidney function damage on in-hospital mortality of cirrhotic patients with acute gastrointestinal bleeding
timeFrame: Through study completion, an average of 1-2 weeks
measure: Effect of terlipressin on the in-hospital mortality of cirrhotic patients with acute gastrointestinal bleeding with ICA-AKI and kidney function damage
timeFrame: Through study completion, an average of 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center for Liver Cirrhosis, The Fifth Medical Center of PLA General Hospital
state: Beijing
city: Beijing
country: China
facility: Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing YouAn Hospital, Capital Medical University
state: Beijing
city: Fuzhou
country: China
facility: Liver Research Center, The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Fuzhou
country: China
facility: Department of Hepatobiliary Disease, 900 Hospital of the Joint Logistics Team (formerly called Fuzhou General Hospital)
state: Fujian
city: Nanchang
country: China
facility: Department of Gastroenterology, The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: Department of Gastroenterology, The First Affiliated Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Department of Critical Care Medicine, The Sixth People's Hospital of Shenyang
state: Liaoning
city: Shenyang
country: China
facility: Department of Gastroenterology, Air Force Hospital of Northern Theater Command
state: Liaoning
city: Shenyang
country: China
facility: Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
state: Liaoning
city: Xi'an
country: China
facility: Department of Gastroenterology, Xi'an Central Hospital
state: Shaanxi
city: Jinan
country: China
facility: Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University
state: Shandong
city: Shanghai
country: China
facility: Eastern Hepatobiliary Hospital of the Second Military Medical University
state: Shanghai
city: Chengdu
country: China
facility: Department of Gastroenterology, General Hospital of Western Theater Command
state: Sichuan
city: Hangzhou
country: China
facility: 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
state: Zhejiang
Study officials:
References:
citation: 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.
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.
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.
citation: 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.