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

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age < 18 years

History of coronary heart disease or ventricular arrhythmia,

Stroke or transient ischemic attack,

Bronchial asthma,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Terlipressin Injectable Product

    Drug

    Terlipressin Injectable Product

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Bolus terlipressinActive comparator 1 intervention
Group B: Continous Infusion of TerlipressinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

Failure to control hemostasis

Time frame
5 days
2

Terlipressin-related complications within 5 days i.e. safety of the drug

Time frame
5 days
3

Number of blood transfusions at 5 days

Time frame
5 days
4

Rebleed within 42 day

Time frame
42 days

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: