Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL
- Conditions
- Acute Variceal Haemorrhage
- Interventions
- Drug: Normal Saline
- Registration Number
- NCT03584087
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TG 0 (0Hr) Normal Saline TG0 will receive 10 ml of 0.9% normal saline (NS) IV bolus q 4 hourly in place of Terlipressin therapy after EVL. TG 2 (48Hr) Terlipressin TG2 will receive Terlipressin (1mg, i.v. Bolus q 4 hourly) therapy for 48 hours after EVL . TG 5 (120Hr) Terlipressin TG5 will receive Terlipressin (1mg, i.v. Bolus q 4 hourly) therapy for 120 hours after EVL .
- Primary Outcome Measures
Name Time Method 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)
Early-Mortality 7 days To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute 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)
Mortality Within 2 Months To evaluate the efficacy of Terlipressin therapy to prevent mortality after EVL in acute VH
- Secondary Outcome Measures
Name Time Method Number of units of Blood transfusion during Hospital Stay In hospital maximum upto 8 weeks Number of units of Blood transfusion during Hospital Stay
Adverse drug events(ADE) 5 days To evaluate ADE associated with Terlipressin therapy
Hospital Stay Maximum 2 Months Duration of hospital Stay
Cost of therapy In hospital maximum upto 8 weeks Total cost of therapy during hospitalization
Complication In hospital maximum upto 8 weeks Hepatic encephalopathy, need for mechanical ventilation, sepsis, shock, hospital acquired Pneumonia
Trial Locations
- Locations (1)
Post Graduate Institute of Medical Education and Research
🇮🇳Chandigarh, India