Efficacy and Safety of Vasopressin Versus Terlipressin as a Second Vasopressor in Critically Ill Cirrhotics With Septic Shock- the VITEL-C Trial

What Was Tested

This registered not phased trial tested Terlipressin.

Sepsis is a life-threatening organ dysfunction caused by dysregulated host response.

A Subset of sepsis is septic shock which has almost 4-6 times the mortality when compared to sepsis.

Septic shock has underlying cellular and metabolic abnormalities in addition to circulatory dysfunction.

It had two arms (groups): Terlipressin (experimental) and Vasopressin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Study design: Prospective open label randomised controlled study.

The study will be conducted in Department of Hepatology ILBS- intensive care unit.

However, the researchers decided to enroll 100 cases randomized into 2 groups, 50 each by block randomization method by taking a block size of 10 Patients will be evaluated in the Emergency Room.

All the infusions will be given via central line placed in the jugular, subclavian or femoral vein by a critical care expert under USG guidance.

Who Took Part

Enrollment: 100 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: An informed consent from the patient or relative.

The full record lists 2 inclusion and 20 exclusion criteria; among the exclusions: age \<18 years and \> 70 years; myocardial dysfunction, coronary artery disease, arrhythmias; peripheral vascular disease.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the Terlipressin group and the comparison group should start out alike.

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

Nothing was hidden in this open-label Terlipressin study: the participants and staff both knew the treatment.

It started in 2022-04-05 with completion listed for 2023-03-31.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 30 secondary outcomes, for example Amount of noradrenaline requirements between in each arm at the end of 6 hours, Need of Renal Replacement Therapy, Incidence of adverse effects till 48 hours after randomization including incidence of rebound hypertension, Mortality at day 28, Days of mechanical ventilation and Days of Intensive Care Unit stay.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Terlipressin in 100 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.