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Trial record 4 of 9 for:    "Esophageal Disease" | "Terlipressin"

Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT03130127
Recruitment Status : Not yet recruiting
First Posted : April 26, 2017
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Xingshun Qi, General Hospital of Shenyang Military Region

Brief Summary:
Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver cirrhosis. According to the drug instructions, intravenous bolus infusion is the standard approach of terlipressin. It remains unclear about whether or not continuous infusion of terlipressin should be considered.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Portal Hypertension Variceal Hemorrhage Bleeding Esophageal and Gastric Varices Drug: Terlipressin Not Applicable

Detailed Description:
Although intravenous bolus infusion of terlipressin is the standard approach, continuous infusion of terlipressin is preferred in clinical practice. The present study is a pilot non-randomized controlled trial to explore the feasibility and safety of continuous infusion of terlipressin for the treatment of acute variceal bleeding in liver cirrhosis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis: A Prospective Non-randomized Controlled Trial
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Cirrhosis

Arm Intervention/treatment
Experimental: Continuous infusion of terlipressin
In our clinical practice, continuous infusion of terlipressin is being employed.
Drug: Terlipressin
According to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis.
Other Name: Glypressin

Active Comparator: Bolus infusion of terlipressin
Traditionally, a bolus infusion of terlipressin is recommended.
Drug: Terlipressin
According to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis.
Other Name: Glypressin




Primary Outcome Measures :
  1. 5 day treatment failure [ Time Frame: 5 days (120 hours) ]
    Death, fresh hematemesis, hypovolaemic shock, or 3 g drop in Hb (9% drop of Ht) within any 24 h period if no transfusion is administered.


Secondary Outcome Measures :
  1. Six-week mortality [ Time Frame: 6 weeks ]
    Death with 6 weeks after treatment


Other Outcome Measures:
  1. Adverse events related to terlipressin [Safety] [ Time Frame: 5 days after treatment ]
    Adverse events related to terlipressin, such as hyponatremia, diarrhea, abdominal pain, arterial hypertension, etc.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A diagnosis of liver cirrhosis;
  2. Child-Pugh B or C;
  3. Acute gastroesophageal variceal bleeding;
  4. Written informed consents. -

Exclusion Criteria:

  1. No liver cirrhosis;
  2. Child-Pugh class A;
  3. Acute upper gastrointestinal bleeding unrelated to varices;
  4. Use of somatostatin or octreotide. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03130127


Contacts
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Contact: Xingshun Qi, MD 86-18909881019 xingshunqi@126.com
Contact: Xiaozhong Guo, MD 86-024-28897613 guo_xiao_zhong@126.com

Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
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Principal Investigator: Xiaozhong Guo, MD General Hospital of Shenyang Military Area

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Responsible Party: Xingshun Qi, Doctor, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT03130127     History of Changes
Other Study ID Numbers: TERLIPRESSIN-LC
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Diseases
Terlipressin
Liver Cirrhosis
Hypertension, Portal
Esophageal and Gastric Varices
Hypertension
Hemorrhage
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases
Gastrointestinal Diseases
Antihypertensive Agents
Vasoconstrictor Agents