Comparison of Terlipressin, Somatostatin, and Octreotide for Control of Variceal Bleeding

Overview

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 Title of Study: “RCT for the Effect of Early Administration of Vasoactive Substances When Combined With Endoscopic Treatment in Acute Gastro-esophageal Variceal Bleeds: Comparisons Among Terlipressin, Somatostatin, and Octreotide”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2010

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

  • Drug: Terlipressin
    • loading with 2 mg IV, and then 1 mg IV every 4 hours for 5 days
  • 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

Arms, Groups and Cohorts

  • Active Comparator: Terlipressin
    • treat with terlipressin IV for 5 days and endoscopic treatment
  • Active Comparator: Somatostatin
    • treat with somatostatin IV for 5 days and endoscopic treatment
  • Active Comparator: Octreotide
    • treat with octreotide IV for 5 days and endoscopic treatment

Clinical Trial Outcome Measures

Primary Measures

  • 5-day Treatment Failure (Failure to Control Bleeding, Rebleeding, or Death)
    • Time Frame: 5 days after enrollment

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Korea University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Soon Ho Um, Professor – Korea University
  • Overall Official(s)
    • Soon Ho Um, Prof, Principal Investigator, Korea University

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