Low Dose Vasopressin in Traumatic Shock

Early Phase 1

Terminated

• Conditions: Injuries; Shock, Traumatic
• Interventions: Drug: normal saline control; Drug: vasopressin

• Registration Number: NCT00420407
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-01-09
• Study First Submitted QC: 2007-01-09
• Study First Posted: 2007-01-11
• Study Start: 2007-02
• Primary Completion: 2009-04
• Study Completion: 2011-02
• Results First Submitted: 2012-09-11
• Results First Submitted QC: 2013-03-05
• Status Verified: 2013-04
• Results First Posted: 2013-04-16
• Last Update Submitted: 2019-06-06
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 81

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);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	normal saline control	bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added
I	vasopressin	Vasopressin

Primary Outcome Measures

Name	Time	Method
The Primary Endpoint of This Study Will be Day 30 Mortality.	30 days	Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.

Secondary Outcome Measures

Name	Time	Method
Level of Vasopressin After Trauma.	12 hours	Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States