Efficacy of Terlipressin Therapy in Acute Variceal Haemorrhage After EVL
Status:
Completed
Trial end date:
2019-07-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Postgraduate Institute of Medical Education and Research