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Not yet recruiting NCT06815770

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

Phase II / Phase III Interventional Acute on Chronic Liver Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Terlipressin Injectable Product.
Who it may be relevant to
Registry conditions: Acute on Chronic Liver Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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

  • Drug Terlipressin Injectable Product
    Terlipressin Injectable Product

Primary outcome measures

  • 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 outcome measures (6)
  • 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 criteria

Inclusion criteria

  • Adult patients (age ≥ 18 years) diagnosed with ACLF presenting with due to esophageal varices bleeding.

Exclusion criteria

  • Age < 18 years
  • History of coronary heart disease or ventricular arrhythmia,
  • Stroke or transient ischemic attack,
  • Bronchial asthma,
  • Epilepsy,
  • Pregnancy,
  • Rebleeding.
  • HCC
  • Gastric variceal bleed

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

India · 1 center
  • Institute of Liver & Biliary Sciences (ILBS) — New Delhi

Identifiers

NCT: NCT06815770 · ILBS-ACLF-22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗