Trial | NCT00369694  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    terlipressin ...

  • Study Participants

    130
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.
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.
Study Started
Aug 31
2006
Primary Completion
Jul 31
2008
Study Completion
Aug 31
2008
Last Update
Sep 25
2008
Estimate

Drug Terlipressin

2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours

  • Other names: Novapressin

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.

  • Other names: Novapressin

1 Active Comparator

72 hours of Terlipressin

2 Placebo Comparator

24 hours of Terlipressin & then next 48 hours of Dummy of Terlipressin

Criteria 

Inclusion Criteria:

Acute esophageal variceal bleed
Liver cirrhosis
Child's score </= 11

Exclusion Criteria:

Patient on Mechanical ventilator and or ionotropic support
Active angina, Recent Myocardial infarction or dynamic EKG changes
Failure to control variceal bleed on initial endoscopy
Gastric variceal bleed
Spontaneous bacterial peritonitis at presentation
Hepatocellular carcinoma or other liver metastatic malignancy
Portal vein thrombosis
No Results Posted