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Efficacy and Safety of Continuous Infusion of Terlipressin vs Bolus Terlipressin in ACLF Patients With Acute Esophageal Variceal Bleed

Status

Not yet recruiting

Phase

Phase 2 / Phase 3

Enrollment

60

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

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

Treatment arms and agents.

DRUG

Terlipressin Injectable Product

Terlipressin Injectable Product

Timeline

From registration to results.

  1. First posted

    Feb 7, 2025

  2. Study start

    Feb 10, 2025

  3. Primary completion

    Feb 28, 2026

  4. Study completion

    Feb 28, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Feb 7, 2025

Outcomes

What the study measures.

Primary 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

Secondary outcomes

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

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

1 registered sites.

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

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Terlipressin.

Related PeptideStat pages

Put the record in context.

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