Low Dose Vasopressin in Traumatic Shock

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Arginine Vasopressin; Vasopressins

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);