AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock

What Was Tested

This registered phase 2 trial tested Vasopressin.

It had two arms (groups): Vasopressin (active comparator) and Normal Saline (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

As such, there exists an urgent need to evaluate novel resuscitation strategies that target neuroendocrine deficiencies in hemorrhagic shock.

The hormone arginine vasopressin (AVP), in particular, may prove a useful adjunct during resuscitation.

Vasopressin has enjoyed widespread off-label use as a vasopressor in cardiac arrest, septic shock, and post-cardiopulmonary vasodilatory shock.

Who Took Part

The registry lists 101 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

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

The full record lists 1 inclusion and 7 exclusion criteria; among the exclusions: patients with an active coronary syndrome, history of myocardial infarction or coronary artery disease will be excluded; patients with known renal dysfunction requiring dialysis will be excluded; patients who are pregnant will be excluded.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Vasopressin 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 Vasopressin.

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

It started in 2013-05-01 with completion listed for 2016-09-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Blood Products Transfused (time frame: 48 hours following the initiation of therapy).

It also tracked 2 secondary outcomes, for example Need for Vasopressor Requirement Vasopressor Requirement and Total Number of Complications.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Vasopressin in 101 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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