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Continuous Versus Bolus Infusion of Terlipressin for Portal Hypertension Related Bleeding in Liver Cirrhosis

Plain-language guide to NCT03130127: not phased non-randomized trial of Terlipressin, 40 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03130127
Phase
not phased
Status
status unknown
Start
2024-07-01
Completion (planned or actual)
2025-12-01
Participants
40 (estimated)
Design
non-randomized, open label (everyone knows who gets what), treatment
Conditions studied
Liver Cirrhosis; Portal Hypertension; Variceal Hemorrhage; Bleeding; Esophageal and Gastric Varices
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Terlipressin.

Terlipressin is the mainstay drug for the treatment of acute variceal bleeding in liver cirrhosis.

According to the drug instructions, intravenous bolus infusion is the standard approach of terlipressin.

It remains unclear about whether or not continuous infusion of terlipressin should be considered.

It had two arms (groups): Continuous infusion of terlipressin (experimental) and Bolus infusion of terlipressin (active comparator).

In their clinical practice, continuous infusion of terlipressin is being employed.

Traditionally, a bolus infusion of terlipressin is recommended.

The registry classes the interventions as drug.

More on the Plan

Although intravenous bolus infusion of terlipressin is the standard approach, continuous infusion of terlipressin is preferred in clinical practice.

The present study is a pilot non-randomized controlled trial to explore the feasibility and safety of continuous infusion of terlipressin for the treatment of acute variceal bleeding in liver cirrhosis.

Who Took Part

Enrollment: 40 planned participants were the target.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: A diagnosis of liver cirrhosis;. Child-Pugh B or C;. Acute gastroesophageal variceal bleeding;. Written informed consents. -.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: no liver cirrhosis;; child-pugh class a;; acute upper gastrointestinal bleeding unrelated to varices;.

How the Study Was Run

Design: non-randomized, parallel-group and open-label.

The Terlipressin group and the comparison group ran side by side rather than switching.

Everyone knew when Terlipressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2024-07-01 with completion listed for 2025-12-01.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 5 day treatment failure (time frame: 5 days (120 hours)).

It also tracked 1 secondary outcome, for example Six-week mortality.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Terlipressin in 40 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Terlipressin compound page, all human trials.

Our Notes on the Compound

Terlipressin: A synthetic vasopressin analog (Terlivaz) used for kidney failure in advanced liver disease and for variceal bleeding.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.