Terlipressin in Septic Shock: Effects on Microcirculation

What Was Tested

This registered phase 2, phase 3 trial tested Terlipressin.

The present study was conducted as a prospective, randomized study to investigate the effects of vasopressin receptor agonists terlipressin and vasopressin on systemic hemodynamics and microcirculation in patients with catecholamine-dependent septic shock.

It had three arms (groups): continuous terlipressin (experimental), vasopressin (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

60 septic shock patients requiring norepinephrine to maintain mean arterial pressure between 65 and 75 mmHg despite adequate volume resuscitation will be enrolled in the study.

In all groups open label norepinephrine will be additionally administered to maintain a mean arterial pressure (MAP) between 65 and 75 mmHg, if necessary.

Data from right heart catheterization and sublingual microvascular network will be obtained just before randomization (baseline) and then after 6 hours in the vasopressin, terlipressin infusion and terlipressin bolus groups.

The device will be applied on the lateral side of the tongue, in an area approximately 2-4 cm from the tip of the tongue.

Who Took Part

The registry lists 60 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 4 exclusion criteria; among the exclusions: age \< 18 years; present or suspected acute mesenteric ischemia; vasospastic diathesis (e.g. raynaud's syndrome or related diseases).

How the Study Was Run

It was run as a randomized, parallel-group and triple-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.

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

Blinding on both sides kept the participants and researchers unaware of who received Terlipressin.

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

It started in 2008-11 with completion listed for 2010-02.

It ran at 1 site in Italy.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Systemic hemodynamic and Microcirculatory flow index of small and medium vessels (MFI) (time frame: over a period of 6 hrs from the time of randomization). Oxygen transport variables (time frame: over a period of 6 from the time of randomization).

It also tracked 5 secondary outcomes, for example Acid-base homeostasis, Functional capillary density (mm/mm2) (FCD), De Backer score, Perfused Vessel Density (PVD) (mm/mm2) and Proportion of Perfused vessels (%) (PPV).

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Terlipressin in 60 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.