The Duration of Octreotide Study. An Assessment of the Duration of Continuous Intravenous Octreotide in Patients with Portal Hypertension and Esophageal Variceal Hemorrhage
The study will compare two durations of treatment with octreotide in patients with confirmed esophageal variceal hemorrhage who have undergone successful endoscopy and possible endoscopic therapy for control of bleeding. All procedures including the treatment are the standard of practice. Octreotide infusion and endoscopic therapy for esophageal variceal bleeding with esophageal banding, hemoclipping, and/or saline and/or ethanolamine injection are not investigational. However the 24 hour infusion of Octreotide for esophageal variceal bleeding is investigational.[Double Quote]
During the screening procedure, the subject may fill out certain forms or have the following exams, tests or procedures:
Physical exam and medical history; Vital signs; Blood tests; and Demographic information (age, sex, ethnic origin).
All qualified patients with suspected esophageal variceal bleeding will be placed on a continuous intravenous octretoide infusion and after successful endoscopic therapy they will be randomized to continue octreotide for 24 or 72 hours. Outcomes that will be measured include rebleeding, need for repeat endoscopic therapy, need for other therapies to control bleeding, Child-Pugh score, MELD score and survival. Rebleeding is one of the outcomes after octreotide treatment. Repeat endoscopic therapy is also a standard of care in routine clinic.
As part of the research, the study coordinator will be in charge of following the patients during the hospitalization. The coordinator will monitor the MAR (Medicine admnistration report) of the enrolled patient to verify that the correct dose and length of time is being given of octreotide. The study coordinator will contact the primary team to remind when the medicine administration must be stopped as per their randomization. The Researchers will collect: physical exam, vital signs, blood test, endoscopy findings, laboratory data, C-P-T score, MELD score,discharge. Data on rebleeding and mortality will be collected during the hospital stay and at a 30 day interval following the discharge date via EPIC or vCDR .
All patients with suspected or confirmed cirrhosis admitted or hospitalized who develop a GI bleed characterized by:
-witnessed or reported vomiting or defecating fresh blood or melena.
-the presence of gross blood on nasogastric tube aspirate.
-black or tarry stools on digital rectal examination.