Cirrhosis, Hematemesis, Melena, Portal Hypertension
Conditions
Keywords
Variceal bleed, Cirrhosis, Vasoactive agents, Terlipressin, Octreotide, Safety & Efficacy
Brief summary
Terlipressin and Octreotide are two common agents used as adjuvants in the management of variceal bleeding. Both agents have been claimed equivalent to endoscopic therapy in randomized studies. There are no head to head clinical trials of these two agents available in the literature. We aimed to compare the efficacy and safety of Terlipressin and Octreotide in combination with Endoscopic Variceal band Ligation (EVL)in patients presenting with Esophageal Variceal Bleed (EVB).
Detailed description
The effectiveness of combining Endoscopic treatment with Octreotide or Terlipressin has not been prospectively studied in esophageal variceal hemorrhage (EVH). This prospective, randomized clinical trial will help us in better patient management more efficiently and cost effectively.
Interventions
DRUGTerlipressin
2 mg stat & then 1 mg q6h iv and Placebo of Octreotide
DRUGOctreotide
Octreotide 50mcg/hr infusion & a placebo of Terlipressin
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All cirrhotic patients with upper GI bleed secondary to esophageal varices of 18 years or more of age
Exclusion criteria
* Ulcerative esophagitis, * Mallory Weiss tear, * Bleeding gastric or duodenal ulcers, * Bleeding from gastric varices or portal hypertensive gastropathy and * Upper GI bleed as a result of thrombocytopenia or bleeding diathesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety & Efficacy | 5 days |
Countries
Pakistan
Outcome results
None listed