Clinical Trial: Short Course Terlipressin for Control of Acute Variceal Bleeding

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Aga Khan University

Current Primary Outcome: Variceal Re-bleed [ Time Frame: 120 hours (5 Days) ]

Original Primary Outcome: Variceal Re-bleed

Current Secondary Outcome:

  • All cause 30 days mortality [ Time Frame: 30 days ]
  • 30 days rebleed [ Time Frame: 30 days from index bleed ]
  • Safety of Terlipressin [ Time Frame: In Hospital safety ]


Original Secondary Outcome: All cause 30 days mortality

Information By: Aga Khan University

Dates:
Date Received: August 24, 2006
Date Started: August 2006
Date Completion:
Last Updated: September 24, 2008
Last Verified: September 2008