Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose Vasopressin Versus Placebo in Traumatic Shock Resuscitation

The University of Texas Health Science Center at San Antonio1 site in 1 country81 target enrollmentFebruary 2007

ConditionsInjuries Shock, Traumatic

Interventionsvasopressin normal saline control

Drugsnormal saline control vasopressin

Overview

Phase: Early Phase 1
Intervention: vasopressin
Conditions: Injuries
Sponsor: The University of Texas Health Science Center at San Antonio
Enrollment: 81
Locations: 1
Primary Endpoint: The Primary Endpoint of This Study Will be Day 30 Mortality.
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

February 2011

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

The University of Texas Health Science Center at San Antonio

Responsible Party

Sponsor

Eligibility Criteria

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);