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Trial record 1 of 1 for:    NCT00420407
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Low Dose Vasopressin in Traumatic Shock

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00420407
Recruitment Status : Terminated (accrual rate)
First Posted : January 11, 2007
Results First Posted : April 16, 2013
Last Update Posted : June 18, 2019
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Injuries Shock, Traumatic Drug: normal saline control Drug: vasopressin Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose Vasopressin Versus Placebo in Traumatic Shock Resuscitation
Study Start Date : February 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: I
Drug: vasopressin
vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours

Placebo Comparator: 2
bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added
Drug: normal saline control
no vasopressin added to bolus or 5 hour continuous infusion

Primary Outcome Measures :
  1. The Primary Endpoint of This Study Will be Day 30 Mortality. [ Time Frame: 30 days ]
    Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.

Secondary Outcome Measures :
  1. Level of Vasopressin After Trauma. [ Time Frame: 12 hours ]
    Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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);

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00420407

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United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
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Principal Investigator: Stephen M. Cohn, MD The University of Texas Health Science Center at San Antonio
Additional Information:
Publications of Results:
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Responsible Party: The University of Texas Health Science Center at San Antonio Identifier: NCT00420407    
Other Study ID Numbers: 056-1502-090
First Posted: January 11, 2007    Key Record Dates
Results First Posted: April 16, 2013
Last Update Posted: June 18, 2019
Last Verified: April 2013

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shock, Traumatic
Pathologic Processes
Wounds and Injuries
Arginine Vasopressin
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs