Comparison of Bolus Versus Continuous Infusion of Terlipressin Cirrhotic Patients With Septic Shock.

What Was Tested

The trial (not phased) is built around Terlipressin.

Septic shock is a major life-threatening vasodilatory shock.

(4)Therefore, newer alternatives like dopamine, dobutamine, somatostatin, and terlipressin are also used.

It had two arms (groups): Terlipressin Bolus Arm (experimental) and Terlipressin Continuous Infusion Arm (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

Global tissue perfusion adequacy and microcirculation assessment was done by * 1\.

SVR index = MAP-CVP/CO \*80 ( 700 - 1500dynes/sec/cm-5 * 2\.

Global EDV = combined end diastolic volume of all 4 chambers. * 3\.

Lactate of Blood Gas preferably * 4\.

Who Took Part

The registry lists 310 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 0 inclusion and 17 exclusion criteria; among the exclusions: patients with age less than 18 years or more than 65 years; severe known cardiopulmonary disease (hypertension, structural or valvular heart disease, coronary artery disease, arrhythmias); peripheral vascular disease.

How the Study Was Run

The set-up was 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

It started in 2021-06-25 with completion listed for 2022-03-19.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Reversal of shock (time frame: 72 hours).

It also tracked 15 secondary outcomes, for example Time to reversal of shock, Incidence of adverse effects and discontinuation of therapy due to adverse effects, Incidence of adverse effects and discontinuation of therapy due to adverse effects, Impact on AKI (Progression, Resolution, requirement of renal replacement therapy, (RRT), Impact on AKI (Progression, Resolution, requirement of renal replacement therapy, (RRT) and Impact on AKI (Progression, Resolution, requirement of renal replacement therapy, (RRT).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Terlipressin in 310 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.