Low Dose Vasopressin in Traumatic Shock

What Was Tested

This registered early phase 1 trial tested Vasopressin.

Hypothesis: the researchers hypothesize that resuscitation regimens which minimize the total volume of resuscitation fluid, while restoring organ perfusion, will lead to lower morbidity and mortality in critically ill patients following trauma.

It had two arms (groups): I (experimental) and 2 (placebo comparator).

Vasopressin.

Bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added.

The registry classes the interventions as drug.

Who Took Part

81 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: Patient is a male or female patient presumed to be at least 18 years of age;. Patient has a systolic blood pressure \< 90 mmHg;. Patient has clinical evidence of acute traumatic injury;. Infusion of study drug must start within one hour following SBP (systolic blood pressure) \< 90 mmHg.

The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: patient is admitted to one of the study hospitals' emergency department greater than six hours after injury;; patient has received greater than 4 liters fluid since time of injury;; patient is enrolled in another shock trial;.

How the Study Was Run

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

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

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

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

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

It started in 2007-02 with completion listed for 2009-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: The Primary Endpoint of This Study Will be Day 30 Mortality (time frame: 30 days).

It also tracked 1 secondary outcome, for example Level of Vasopressin After Trauma.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Vasopressin in 81 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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