DRUG
Terlipressin Injectable Product
Terlipressin Injectable Product
Status
Not yet recruiting
Phase
Phase 2 / Phase 3
Enrollment
60
Locations
1
Results
Not posted
Publications
0
Study summary
Acute portal hypertension, as measured by rapid rise in hepatic venous pressure gradient (HVPG) can lead to further dreaded complications, including acute variceal bleeding (AVB) AVB: 6-week mortality rates of around 15-20% in patients with chronic liver disease without ACLF.The overall prevalence of UGH in cirrhotic patients with AD was 34.4% and 35.7% in patients with ACLF.AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. AVB is a well-recognized precipitant leading to the occurrence and development of ACLF. Medical therapy for esophageal variceal bleeding (EVB) aims to reduce the splanchnic blood flow and portal pressure. The most common vasoactive agents include terlipressin, vasopressin, somatostatin, and octreotide.
Aim and Objective - To assess the safety and efficacy of continuous terlipressin vs. Bolus terlipressin in the management of acute esophageal variceal bleeding in ACLF. Study population: Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with upper GI bleeding due to esophageal varices Study design: Pilot study Study period: 1 year Sample size: 60 Intervention: Group I- Intravenous terlipressin (administered as a continuous infusion at 4 mg/24 hours). After 12 hours, if the hepatic venous pressure gradient (HVPG) does not show a reduction of less than 10%, increase the dose to 6 mg/24 hours. Group II- Intravenous terlipressin (2 mg initially every 4 hourly for 2 days and then 1 mg every 4 hrs) Monitoring and assessment: All patients would undergo vital and baseline parameter screening before randomization. Based on randomization they will receive either steroid or plasma exchange followed by steroid Adverse effects: Acute Diarrhea, chest pain, Arterial hypertension, Cardiac arrhythmias, Acute abdomen Stopping rule: chest pain, alteration of ECG, cyanosis, bradycardia, severe allergic rashes
Interventions
DRUG
Terlipressin Injectable Product
Timeline
First posted
Feb 7, 2025
Study start
Feb 10, 2025
Primary completion
Feb 28, 2026
Study completion
Feb 28, 2026
Results posted
Not reported
Registry updated
Feb 7, 2025
Outcomes
Hepatic venous Pressure Gradient (HVPG) reduction of more than 10% from baseline at 12-24 hours in both arms.
Time frame · 12-24 hours
Failure to control hemostasis
Time frame · 5 days
Terlipressin-related complications within 5 days i.e. safety of the drug
Time frame · 5 days
Number of blood transfusions at 5 days
Time frame · 5 days
Rebleed within 42 day
Time frame · 42 days
Incidence of post-bleed Acute Kidney Injury within 5 days
Time frame · 5 days
6 weeks mortality in both groups.
Time frame · 6 weeks
Eligibility
Inclusion Criteria: 1. Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with due to esophageal varices bleeding. Exclusion Criteria: 1. Age \< 18 years 2. History of coronary heart disease or ventricular arrhythmia, 3. Stroke or transient ischemic attack, 4. Bronchial asthma, 5. Epilepsy, 6. Pregnancy, 7. Rebleeding. 8. HCC 9. Gastric variceal bleed
Study locations
India. Showing up to 24 locations stored in the fast local snapshot.
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India
Publications
No PMID-linked publications were present in this registry snapshot.
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