Efficacy and Safety of Monotherapy With Noradrenaline and Terlipressin in Patients of Cirrhosis With Septic Shock Admitted to Intensive Care Unit

What Was Tested

This registered not phased trial tested Terlipressin.

The Patient evaluated in Emergency room since admission and detailed history and clinical examination done .The in hospital cases where sepsis is the culprit and shifted to Intensive Care Unit (ICU) in view of septic shock were included since onset of shock.

At the same time the strict vitals monitoring and standard medical therapy for sepsis including antibiotics and other supportive therapy continued.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 84 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: An informed consent from the patient or relative.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: pronounced 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); previous history of transplantation on immunosuppressant.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Terlipressin and who got the comparison, which limits bias.

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 2012-10 with completion listed for 2014-09.

It ran at 1 site in India.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example Mortality, Number of organ system involved as defined by SOFA (Sequential Organ Failure Assessment), Days free of vasopressors, Days free of ventilatory support, Days free of steroid and Length of stay.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Terlipressin in 84 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.