This study evaluates the safety and efficacy of 24-hour vs 72-hour octreotide infusion after variceal banding in cirrhotic patients with bleeding esophageal varices.
In cirrhotic patients with bleeding esophageal varices, standard of care therapy includes administration of octreotide infusion over 72-hours and endoscopic banding of esophageal varices. Octreotide acts to reduce the pressure in the blood vessels surrounding the liver, decreasing the propensity of bleeding from esophageal varices. The recommended duration of octreotide therapy is based largely on expert opinion, however a 72-hour duration of treatment is likely to be unnecessary and may inappropriately increase hospital and medical costs. This study aims to determine the safety of 24-hours of octreotide infusion in patients with bleeding esophageal varices.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
34
Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
University of Florida Health
Jacksonville, Florida, United States
University of Illinois at Chicago
Chicago, Illinois, United States
The Ohio state University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Esophageal Varices Rebleed Within 72-hours After Control of Initial Bleed
Rebleeding within 72-hours will be defined as any of the following: 1. A drop in hemoglobin by more than 20 percentage points from baseline 2. Sustained tachycardia above 100 beats per minute, with or without hematochezia or melena 3. Transfusion of \>2 unites packed red blood cells after esophageal band ligation 4. Recurrence of hematemesis or ongoing melena 5. Urgent or emergent need for Transjugular Intrahepatic Portosystemic Shunt (TIPS) to control suspected rebleeding
Time frame: 72 hours
Esophageal Varices Rebleed at 7 Days and 30 Days After Control of Initial Bleed
Rebleeding after 72-hours will be defined as: 1. Any new episode of hematemesis, melena, or hematochezia (with hemodynamic instability) 2. Drop in hemoglobin by more than 20 percentage points OR the need for \>2 units packed red blood cells 3. Need for TIPS or surgery to control suspected bleeding
Time frame: 7 days and 30 days
Survival at 7 Days and 30 Days After Control of Initial Bleed
Survival at 7 days and 30 days.
Time frame: 7 days and 30 days
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Medical University of South Carolina
Charleston, South Carolina, United States
The University of Texas at Austin
Austin, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Brooke Army Medical Center
Houston, Texas, United States