Terlipressin Adverse Reaction Clinical Trial
Official title:
Terlipressin Bolus Versus Continuous Infusion in Patients With Variceal Hemorrhage
Randomized, open label study of intravenous terlipressin infusion vs. bolus for the treatment of variceal hemorrhage. 24 hour regimen consisting of intravenous terlipressin will be used either at a rate of 0.5mg/hour or 2mg bolus every 4 hourly. Participants will be randomized into intervention and control arm using block randomization by computer generated random numbers. Efficacy will be assessed by clinical improvement in symptoms and signs of GI bleed. To assess safety, frequency and degree of adverse reactions will be observed. Periodic assessments until 5 days will be done consisting of physical examination, safety assessments, vital signs and lab tests.
Randomized, open label trial, conducted on patients admitted with acute variceal hemorrhage
at The Aga Khan University Hospital, Karachi (AKUH). Patients will be followed in clinic
after discharge to assess survival for 6 weeks.
Intravenous terlipressin will be obtained from Clinical Trials Unit, AKUH pharmacy in
standard IV infusion form. Following complete clinical and laboratory evaluation, assessing
the patient for eligibility, informed consent will be obtained from all the participants who
are willing to be part of this study. After obtaining the informed consent, study
participants will be randomized into the intervention arm (continuous infusion of
Terlipressin) or the control arm (bolus form of Terlipressin). Participants who are
randomized to the intervention arm will be administered a continuous infusion of Terlipressin
at a rate of 0.5mg/hour for the first 24 hours. Participants randomized into the control
group will be administered a bolus form of Terlipressin at a rate of 2mg every six hourly for
the first 24 hours respectively. In case of weekends/public holidays intravenous terlipressin
will be obtained from the main pharmacy of AKUH.
The trial will be conducted in in-patient units of AKUH where eligible patients are admitted.
It may include emergency room, special care unit and general ward. Moreover, patients will be
followed up by phone calls and in outpatient's clinics to assess survival six weeks post
discharge.
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