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Variceal HemorrhageNCT03846180

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

An observational study of Variceal Hemorrhage and Cirrhosis, Liver, run by General Hospital of Shenyang Military Region at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
What is being tested?
Terlipressin, Somatostatin and Octreotide
Type of treatment
Injection or infusion
How many people
1,682 participants
Where
14 sitesChina
Study dates
1 Mar 2019to 1 Jul 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Cirrhotic patients with acute gastrointestinal bleeding received terlipressin or somatostatin/octreotide.

Who may be able to join

  • Cirrhotic patients who were admitted between January 2010 and December 2018.
  • A diagnosis of acute gastrointestinal bleeding.
  • Patients who received terlipressin or somatostatin/octreotide.
  • Age or sex was not limited.
  • Use of endoscopy was not limited.
  • Comorbidity was not limited.
  • Malignancy was not limited.

Who cannot join

  • Renal parenchymal diseases.
  • Absence of baseline serum creatinine.
  • Absence of serum creatinine 3-5 days after terlipressin or somatostatin/octreotide.
  • Duration of terlipressin or somatostatin/octreotide was less 3 days.
  • Patients who underwent transjugular intrahepatic portosystemic shunt.
  • Patients who underwent surgical shunt, splenectomy with or without devascularization, or liver transplantation.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

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

    Beijing, Beijing Municipality, 100039

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

    Beijing, Beijing Municipality, 100069

  • Department of Gastroenterology, General Hospital of Western Theater Command

    Chengdu, Sichuan, 610083

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

    Fuzhou, Fujian, 350005

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

    Fuzhou, Fujian, 350025

  • 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, 310003

  • Department of Gastroenterology, Shandong Provincial Hospital Affiliated to Shandong University

    Jinan, Shandong, 250021

  • Department of Gastroenterology, The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Eastern Hepatobiliary Hospital of the Second Military Medical University

    Shanghai, Shanghai Municipality

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

    Shenyang, Liaoning, 110001

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

    Shenyang, Liaoning, 110006

  • Department of Gastroenterology, Air Force Hospital of Northern Theater Command

    Shenyang, Liaoning, 110042

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

    Shenyang, Liaoning, 110840

  • Department of Gastroenterology, Xi'an Central Hospital

    Xi'an, Shaanxi, 710000

Other trials in China

About this study

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

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.

Being tested
Terlipressin, Somatostatin, Octreotide
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TerlipressinDrug

    Also called Glypressin

    Continuous or intermittent intravenous infusion of terlipressin was given.

  • SomatostatinDrug

    Also called Stilamin

    Continuous or intermittent intravenous infusion of somatostatin was given.

  • OctreotideDrug

    Also called Sandostatin

    Continuous or intermittent intravenous infusion of octreotide was given.

Study groups in NCT03846180
Study groupRoleWhat they receive
Terlipressin groupCirrhotic patients with acute gastrointestinal bleeding received terlipressin with or without somatostatin/octreotide.
Receives: Drug: Terlipressin
Somatostatin/Octreotide groupCirrhotic patients with acute gastrointestinal bleeding received somatostatin and/or octreotide without terlipressin.
Receives: Drug: Somatostatin; Drug: Octreotide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of ICA-AKI and kidney function damage in cirrhotic patients with acute gastrointestinal bleeding

    ICA-AKI and kidney function damage

    Measured: Through study completion, an average of 1-2 weeks

  2. Effect of ICA-AKI and kidney function damage on in-hospital mortality of cirrhotic patients with acute gastrointestinal bleeding

    In-hospital mortality

    Measured: Through study completion, an average of 1-2 weeks

  3. 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

    Measured: Through study completion, an average of 1-2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2019
  2. Study start1 Mar 2019
  3. Primary completion30 Jun 2019
  4. Study completion1 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,682 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03846180
Sponsor's protocol ID
XHNKKY-VASO 2.0
Status last verified
Jul 2019
First submitted
14 Feb 2019
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: This plan to share the individual patient data has been not decided yet.

Publications

  • 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.

    PubMed 30474439

  • 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.

    PubMed 30508958

  • 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.

    PubMed 29996332

  • 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.

    PubMed 32860184

Questions about this trial

What is this clinical trial studying?

An observational study of Variceal Hemorrhage and Cirrhosis, Liver, run by General Hospital of Shenyang Military Region at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03846180, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.

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