Vasopressin Versus Catecholamines for Cerebral Perfusion Pressure Control in Brain Injured Trauma Patients

What Was Tested

In this not phased trial, researchers set out to test Vasopressin.

The damage that occurs at the instant of trauma cannot be modified; the secondary injuries that occur afterward are the impediments to recovery and can be influenced by the physician.

Cerebral ischemia is the most important secondary event that determines outcome following TBI.

It had two arms (groups): AVP, arginine vasopressin (active comparator) and Standard Catecholamine (active comparator).

Vasopressin.

Levophed, dopamine, phenylephrine).

The registry classes the interventions as drug.

More on the Plan

This is a randomized, controlled, open-label clinical trial comparing vasopressin and catecholamines for cerebral perfusion pressure (CPP) control after a traumatic brain injury (TBI).

Once a neurosurgeon is consulted for a patient presenting with a TBI, they will review entry criteria and refer to study personnel to obtain informed consent.

After informed consent, subjects will be randomized into one of the 2 groups to receive either a catecholamine at the discretion of the attending physicians or vasopressin (AVP).

The amount of study drug will be titrated to maintain cerebral perfusion pressure within normal limits.

Who Took Part

96 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: Age \>/= 18 yrs,. Primary admission to the hospital within 8 h after injury. Closed head injury. Potential for intracranial pressure monitoring.

The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: pregnant or nursing women; hemodynamic instability after initial resuscitation; vasopressor therapy for greater than 6 hours.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

The Vasopressin group and the comparison group ran side by side rather than switching.

Being open-label, the Vasopressin study did not mask who received what.

It started in 2008-09 with completion listed for 2014-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vasopressin in 96 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.