Clinical trial NCT00369694: Short Course Terlipressin for Control of Acute Variceal Bleeding
Official title: Randomized Double Blind Dummy Controlled Trial Of 24 Versus 72 Hours Of Terlipressin As An Adjuvant Therapy In Acute Variceal Bleed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hemorrhage
Esophageal Varices
Portal Hypertension
Keywords: Esophageal varices
Portal Hypertension
Melena
Hematemesis
Gastrointestinal Hemorrhage
Terlipressin
Efficacy
Safety
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: Ferozsons Laboratories Ltd.
First posted: 2006-08-29
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: Variceal Re-bleed
timeFrame: 120 hours (5 Days)
Secondary outcomes:
measure: All cause 30 days mortality
timeFrame: 30 days
measure: 30 days rebleed
timeFrame: 30 days from index bleed
measure: Safety of Terlipressin
timeFrame: In Hospital safety
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: The Aga Khan University Hospital
state: Sindh
Study officials:
affiliation: The Aga Khan University Hospital
name: Saeed S Hamid, FRCP, FACG
role: STUDY_CHAIR
affiliation: The Aga Khan University Hospital
name: Zahid SM Azam, MBBS, FCPS
role: STUDY_DIRECTOR
affiliation: The Aga Khan University Hospital
name: Wasim SM Jafri, FRCP, FACG
role: STUDY_DIRECTOR
References: