drugset / Trial / NCT02757703

Vasoactive Drugs in Real World Practice

NCT02757703

Phase 4 Completed 150 enrolled Kaohsiung Veterans General Hospital.
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2010-05
Primary completion
2015-01
Completion
2015-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Somatostatin Traditional medicine (herbal / TCM) 250 ug Intravenous
Comparator Terlipressin Peptide 1 mg
Comparator Pantoprazole Other / unclassified 40 mg Intravenous