Acute Variceal Haemorrhage
Conditions
Keywords
Terlipressin, Variceal Haemorrhage, EVL
Brief summary
Upper gastrointestinal (UGI) bleed of variceal origin is a common medical emergency. Prompt endoscopic variceal ligation (EVL) is therapeutic as well as diagnostic. Terlipressin, a vasopressin analog (intravenous, 2 mg q 4 hourly), is widely used promptly in any suspicious case of variceal haemorrhage (VH) before endoscopic procedure, along with volume and blood resuscitative measures. As per guideline, after EVL Terlipressin therapy (1 mg IV q 4 hourly) is continued for 2-5 day to prevent re-bleed. But the prolong use of Terlipressin is not completely safe as well as it is expensive also in resource constraint setting. At present there is no clinical trial available to prove the efficacy of post-EVL Terlipressin therapy in preventing re-bleed and mortality in cases of acute variceal haemorrhage. During the post marketing surveillance Terlipressin therapy has been found to be associated with life threatening complication like cardiac arrhythmia, myocardial ischemia, critical vasoconstriction of peripheral as well as internal organ leading to ischemia or gangrene, severe hyponatremia, hypertension, fluid overload and pulmonary oedema. So the justification of continuing Terlipressin therapy for 5 days after EVL is questionable, as haemostasis is primarily achieved by EVL and the risk versus benefit of Terlipressin therapy after EVL is still unknown. Continue IV Terlipressin therapy also prolongs in-hospital care causing further increase of health care burden. There is still lack of data of Terlipressin therapy, regarding its efficacy in preventing post-EVL re-bleed, mortality, adverse drug events and cost effectiveness. The investigator will study to evaluate the utility of Terlipressin therapy after EVL, in acute variceal haemorrhage.
Interventions
DRUGNormal Saline
TG 0 (0Hr)
DRUGTerlipressin
Duration of Terlipressin after EVL
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Irrespective of gender with age ≥ 18 years * All the patients with endoscopy proven acute variceal haemorrhage (VH) * Receiving Pre-EVL Terlipressin therapy * EVL done within 24 hours of presentation * Ready to give written informed consent
Exclusion criteria
* Patients with UGI bleed for more than 24 hours * Not receiving pre-EVL Terlipressin therapy * Pregnancy * Past history of EVL * Chronic kidney disease * Patient's with EVL done beyond 24 hours of admission because of hemodynamic instability or encephalopathy * Patients who are receiving blood thinners like anti-platelets, anti-coagulation agents within 4 weeks of presentation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Early-Rebleed | 5 days | To evaluate the efficacy of Terlipressin therapy to prevent re-bleed after EVL in acute variceal Haemorrhage (VH) |
| Number of participants with Rebleed | Within 2 Months | To evaluate the efficacy of Terlipressin therapy to prevent re-bleed after EVL in acute variceal Haemorrhage (VH) |
| Early-Mortality | 7 days | To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH |
| Mortality | Within 2 Months | To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse drug events(ADE) | 5 days | To evaluate ADE associated with Terlipressin therapy |
| Complication | In hospital maximum upto 8 weeks | Hepatic encephalopathy, need for mechanical ventilation, sepsis, shock, hospital acquired Pneumonia |
| Hospital Stay | Maximum 2 Months | Duration of hospital Stay |
| Number of units of Blood transfusion during Hospital Stay | In hospital maximum upto 8 weeks | Number of units of Blood transfusion during Hospital Stay |
| Cost of therapy | In hospital maximum upto 8 weeks | Total cost of therapy during hospitalization |
Countries
India
Outcome results
None listed