Terlipressin Alone Versus the Standard Therapy With Catecholamines for Hepatic Patients With Septic Shock- Prospective Single Center Randomized Controlled Study.

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test Terlipressin.

The purpose of this study is to evaluate the use of terlipressin compared to standard regimen in hepatic patients with septic shock.

Another aim is to compare the mortality rate \& the effects on renal functions in both groups.

It had two arms (groups): nor-epinephrine+/- epinephrine infusion (active comparator) and Terlipressin infusion (other).

The registry classes the interventions as drug.

More on the Plan

Study type: This is a single center, prospective randomized controlled study.

Raynaud's syndrome or related diseases) or hypersensitivity to terlipressin.

IVi \& can be titrated every 15-30min.

Vital signs including the heart rate, mean arterial pressure (MAP) through arterial cannula, central venous pressure (CVP) through a catheter inserted either in the internal jugular vein or the subclavian vein will be measured at admission and at regular intervals.

Who Took Part

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.

The full record lists 1 inclusion and 1 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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.

In this single-blind Terlipressin study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2018-07-01 with completion listed for 2020-07.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hemodynamic stability & optimization; mean blood pressure more than or equal 65mmHg (time frame: 48hours up to 7days). mortality (time frame: 28 days). Hemodynamic stability & optimization; mean blood pressure (time frame: 48hours up to 7days).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, 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.