Continuous Infusion of Terlipressin in Septic Shock

What Was Tested

The trial (phase 2) is built around Terlipressin.

It had three arms (groups): 1 (experimental), 2 (experimental) and 3 (active comparator).

Terlipressin.

Vasopressin.

Titrated norepinephrine.

The registry classes the interventions as drug.

More on the Plan

Forty-five septic shock patients requiring vasopressor support to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation were enrolled in the study.

In both the terlipressin and vasopressin group, norepinephrine was additionally administered to achieve a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary.

Data from right heart catheterization, thermo-dye dilution catheter, gastric tonometry as well as data from organ function, cytokines concentrations, were obtained at baseline and after 12, 24, 36 and 48 hours.

Who Took Part

The registry lists 45 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Clinical diagnosis of Septic shock.

The full record lists 2 inclusion and 3 exclusion criteria; among the exclusions: present cardiac dysfunction; present or suspected acute mesenteric ischemia.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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.

Neither the participants nor the staff measuring them knew who was on Terlipressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2007-01 with completion listed for 2007-12.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Systemic and regional hemodynamics (time frame: during the first 48 hours from the onset of septic shock).

It also tracked 1 secondary outcome, for example Markers of inflammation,organ functions,adverse effects.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Terlipressin in 45 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.