NCT00369694

Short Course Terlipressin for Control of Acute Variceal Bleeding

Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Aga Khan University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether 24 hours of Terlipressin is as effective as 72 hours of Terlipressin in preventing re-bleed once esophageal variceal bleed has been controlled with endoscopic therapy (variceal band ligation or sclerotherapy) in low to moderate risk variceal bleed patients and hence can save cost and may decrease length of hospital stay especially in the I.C.U or high dependency units.

Detailed description

The esophageal variceal bleeding is usually controlled with endoscopic treatment of variceal band ligation or sclerotherapy along with vasoactive drugs like Terlipressin or Octreotide. The risk of re-bleeding is highest during the initial 5 days from first presentation. Terlipressin is usually given for 3 days (72 hours). In this study we are trying to prove that among low to moderate risk patients, a short course of 1 day (24 hours) of Terlipressin is as effective as 3 days (72 hours) in preventing re-bleed once bleeding has been controlled with endoscopic therapy. This intervention will save 2 days cost incurred on the Terlipressin and may also help in decreasing the length of hospital stay in future.

Conditions

• Hemorrhage
• Esophageal Varices
• Portal Hypertension

Interventions

Type	Name	Description
DRUG	Terlipressin	2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours
DRUG	Terlipressin & then Dummy	2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours.

Timeline

• Start date: 2006-08-01
• Primary completion: 2008-07-01
• Completion: 2008-08-01
• First posted: 2006-08-29
• Last updated: 2008-09-25

Locations

1 site across 1 country: Pakistan