Low Dose Vasopressin in Traumatic Shock

Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00420407
• Other study ID #: 056-1502-090
• Status: Terminated
• Phase: Early Phase 1
• Start date: February 2007
• Est. completion date: February 2011

Study information

• Verified date: April 2013
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. completion date: February 2011
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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);

Related Conditions & MeSH terms

• Injuries
• Shock
• Shock, Traumatic

Intervention

Drug:
• normal saline control
no vasopressin added to bolus or 5 hour continuous infusion
• vasopressin
vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

References & Publications (1)

Cohn SM, McCarthy J, Stewart RM, Jonas RB, Dent DL, Michalek JE. Impact of low-dose vasopressin on trauma outcome: prospective randomized study. World J Surg. 2011 Feb;35(2):430-9. doi: 10.1007/s00268-010-0875-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Endpoint of This Study Will be Day 30 Mortality.	Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.	30 days
Secondary	Level of Vasopressin After Trauma.	Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm	12 hours

External Links

•   Department of Surgery Web Page, Vasopressin presentation