To Assess the Efficacy of Early Introduction of a Combination of Low Dose Vasopressin Analogue in Addition to Noradrenaline as a Vasopressor in Patients of Cirrhosis With Septic Shock

What Was Tested

In this not phased trial, researchers set out to test Terlipressin.

The consecutive patients admitted to Intensive care unit of Hepatology department of ILBS and full filling all the eligibility criteria will be enrolled in 1:1 ration by the process of randomization.- The study is an open level study.

It had two arms (groups): one (experimental) and Noradrenaline (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 184 actual participants took part.

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: Cirrhosis with septic shock not responding to fluid resuscitation within 2 hrs.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: ECG (ElectroCardiography)changes at presentation which exclude the use of vasopressin analouges; cardiac dysfunction ( valvular heart disease, coronary artery disease); acute mesenteric ischemia (confirmed or suspected) or vasospastic diathesis (e.g. reynaud's syndrome or related diseases).

How the Study Was Run

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

Because people in this Terlipressin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2015-05-01 with completion listed for 2017-05-31.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Target MAP (Mean Arterial Pressure) >65 mm Hg at 6 hrs (time frame: 6 hours).

It also tracked 14 secondary outcomes, for example Maintenance of target MAP (Mean Arterial Pressure), Survival, Survival, Microcirculation (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference),, Tissue perfusion (lactate level, Lactate clearance, SCVO2, ABG-VBG Pco2 difference), and Effect on - AKI (Acute kidney Injury),.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Terlipressin in 184 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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