DRUG
Terlipressin
loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding
Status
Completed
Phase
Phase 4
Enrollment
1,034
Locations
1
Results
Posted
Publications
0
Study summary
What the protocol is testing.
This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.
Full detailed description
In patients who are suspected to have variceal bleedings, pharmacologic therapy with vasoactive drugs such as terlipressin, somatostatin, and octreotide is recommended as soon as possible, even before endoscopy. However, it is still unclear whether the efficacies of these drugs are same or not. This study is performed to compare the efficacy of terlipressin, somatostatin, and octreotide in patients with variceal bleeding for the control of variceal bleeding in combination with endoscopic therapy.
Interventions
Treatment arms and agents.
DRUG
Somatostatin
loading with 250 microgram IV, and then 250 microgram/hour continuous IV for 5 days
DRUG
Octreotide
loading with 50 microgram IV, and then 25 microgram/hour continuous IV for 5 days
Timeline
From registration to results.
First posted
Aug 26, 2009
Study start
Sep 2006
Primary completion
May 2010
Study completion
May 2010
Results posted
Mar 19, 2018
Registry updated
Mar 19, 2018
Outcomes
What the study measures.
Primary outcomes
5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)
Time frame · 5 days after enrollment
Secondary outcomes
Active Bleeding During the First Endoscopic Exam, Needing Blood Transfusion for 5 Days, Experiencing Adverse Effects
Time frame · 5 days after enrollment
at least one of the three criteria
Eligibility
Who can take part.
- Minimum age
- 16 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * liver cirrhosis * age between 16 and 75 years * Patients who have upper GI bleeding symptoms (hematemesis or melena) within 24 hours before enrollment * Patients whose systolic blood pressure \<100 mmHg or pulse rate \>100/min at the enrollment * Patients who were not performed endoscopic or pharmacologic therapy for varices * Signed informed consent Exclusion Criteria: * Pregnancy * Positive anti-HIV Ab * A history of severe side-effects or contraindications to study drugs * Severe cardiovascular diseases: acute myocardial infarction, A-V block, congestive heart failure, ischemic heart disease, hypertension (systolic blood pressure \>170 mmHg or diastolic pressure \>100 mmHg) * Chronic renal failure * Hepatocellular carcinoma with protal vein thrombosis * Coexisting malignancy except hepatocellular carcinoma
Study locations
1 registered sites.
South Korea. Showing up to 24 locations stored in the fast local snapshot.
Korea University Anam Hospital
Seoul, South Korea
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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