Esophageal Varices, Hemorrhage, Portal Hypertension
Conditions
Keywords
Esophageal varices, Portal Hypertension, Melena, Hematemesis, Gastrointestinal Hemorrhage, Terlipressin, Efficacy, Safety
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.
Interventions
DRUGTerlipressin
2 mg Terlipressin stat, then 1 mg q6h for total of 72 hours
DRUGTerlipressin & 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.
Sponsors
Ferozsons Laboratories Ltd.
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Variceal Re-bleed | 120 hours (5 Days) |
Secondary
| Measure | Time frame |
|---|---|
| All cause 30 days mortality | 30 days |
| 30 days rebleed | 30 days from index bleed |
| Safety of Terlipressin | In Hospital safety |
Countries
Pakistan
Outcome results
None listed