Hemodynamic Effects of Vasopressin in Early Septic Shock Stage

What Was Tested

The trial (not phased) is built around Vasopressin.

Vasopressin is a vasopressor used in patients with septic shock.

However, its systemic hemodynamic effects and its microcirculation effects are not completely known and understood.

This study aimed to evaluate the effect of exogenous vasopressin on sublingual microcirculation using the sidestream dark field technique and to correlate it with its systemic effects.

It had 1 arm (groups): Vasopressin (other).

The registry classes the interventions as drug.

More on the Plan

Vasopressors were used to maintain mean arterial pressure above 65 mmHg.

Samples were collected for blood gas analysis and arterial and mixed venous blood lactate.

Direct analysis of the sublingual microcirculation was done at that time by videomicroscopy obtained by SDF (Microscan; MicroVision Medical, Amsterdam, Netherlands), following the protocol previously described.

Briefly, after removal of secretions, the lens of SDF was placed in the sublingual space without exerting any pressure.

Who Took Part

18 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: Patients over 18 years. Septic shock using adrenergic vasopressors for less than 48 hours. Arterial catheter and pulmonary artery catheter with semi measurement of cardiac output by thermodilution (Vigilance, Edwards Lifesciences, Irvine, CA, USA) inserted. Signed consent declaration.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: acute coronary disease; suspected or confirmed acute mesenteric ischemia; raynaud's phenomenon.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Vasopressin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2008-05 with completion listed for 2013-04.

It ran at 1 site in Brazil.

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: The primary objective of this study was to evaluate the effect of vasopressin infusion in microcirculation of septic shock patients (time frame: one hour after vasopressin initiation).

What This Means in Plain Language

Put simply, this is a not phased trial of Vasopressin in 18 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, all human trials.