Short Course Terlipressin for Control of Acute Variceal Bleeding

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemorrhage, Esophageal Varices, Portal Hypertension

Intervention / Treatment
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* Drug: Terlipressin
* Drug: Terlipressin & then Dummy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>72 hours of Terlipressin | Drug: Terlipressin<br>* 2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours<br>* Other names: Novapressin;|
| Placebo Comparator: 2<br>24 hours of Terlipressin & then next 48 hours of Dummy of Terlipressin | Drug: Terlipressin & then Dummy<br>* 2 mg Terlipressin stat then 1 mg q6 hours for 24 hours, then a Dummy of Terlipressin q6 hours for the next 48 hours.<br>* Other names: Novapressin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variceal Re-bleed |  | 120 hours (5 Days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause 30 days mortality |  | 30 days | 
| 30 days rebleed |  | 30 days from index bleed | 
| Safety of Terlipressin |  | In Hospital safety | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal varices, Portal Hypertension, Melena, Hematemesis, Gastrointestinal Hemorrhage, Terlipressin, Efficacy, Safety