Low Dose Vasopressin in Traumatic Shock

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2011-02-28

Brief Summary

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Hypothesis: We 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.

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Detailed Description

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Conditions

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Injuries Shock, Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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I

Vasopressin

Group Type EXPERIMENTAL

vasopressin

Intervention Type DRUG

vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours

2

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

Group Type PLACEBO_COMPARATOR

normal saline control

Intervention Type DRUG

no vasopressin added to bolus or 5 hour continuous infusion

Interventions

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normal saline control

no vasopressin added to bolus or 5 hour continuous infusion

Intervention Type DRUG

vasopressin

vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment:

* 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

Exclusion Criteria

A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment:

* 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;
* Patient is asystolic or requires CPR (cardiopulmonary resucitation) prior to randomization;
* Female patient is pregnant by report or suspicion;
* Patient has known "Do Not Resuscitate" orders or visible/identifiable method of objection to participation (e.g., exclusion bracelet);

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No