Overview

Vasoactive Drugs in Real World Practice

Status:
Completed
Trial end date:
2015-01-01
Target enrollment:
0
Participant gender:
All
Summary
Various vasoactive drugs are recommended to use in combination with endoscopic variceal ligation (EVL) in treating acute esophageal variceal bleeding (EVB). The efficacy and drug choice of vasoactive agents under Taiwan's National Health Insurance program remain to be validated. The aim of this prospective cohort study was to assess the efficacy of somatostatin, compared with terlipressin in cirrhotic patients who have acute EVB and received EVL and the preference of vasoactive agents in real-world clinical practice. From April 2010 through April 2015, cirrhotic patients with significant upper gastrointestinal bleeding were screened. Eligible patients with acute EVB were non-randomly assigned to receive early administration of somatostatin (group S) or terlipressin (group T) infusion, followed by EVL. A decision to use vasoactive drugs depended on the physician's favorite. In group S, somatostatin by intravenous bolus (250 μg) followed by 250 μg/hour was continued for 3 days. In group T, terlipressin was started with 2mg bolus injection and followed by 1 mg infusion every 6 hours for 3 days.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kaohsiung Veterans General Hospital.
Treatments:
Lypressin
Pantoprazole
Somatostatin
Terlipressin
Criteria
Inclusion Criteria:

- acute hemorrhage from esophageal varice(s)

- portal hypertension attributed by cirrhosis

- age was between 20 and 80 years old

Exclusion Criteria:

- being associated with hepatocellular carcinoma (HCC) of Barcelona-Clinic Liver Cancer
(BCLC) > C

- being associated with severe illness such as chronic obstructive pulmonary disease
(COPD), septic shock, cerebral vascular event, acute coronary syndrome and uremia

- with current gastric variceal bleeding

- ever underwent endoscopic injection sclerotherapy (EIS), EVL within 6 month prior to
current bleeding episode

- ever received shunt or transjugular intrahepatic porto-systemic stent shunt (TIPS)
procedure

- allergic to and/or with contraindications of vasopressors

- pregnancy.