Status:
TERMINATED
Low Dose Vasopressin in Traumatic Shock
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Injuries
Shock, Traumatic
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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);
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00420407
Start Date
February 1 2007
End Date
February 1 2011
Last Update
June 18 2019
Active Locations (1)
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1
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229