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Low Dose Vasopressin in Traumatic Shock

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ClinicalTrials.gov Identifier: NCT00420407
Recruitment Status : Terminated (accrual rate)
First Posted : January 11, 2007
Results First Posted : April 16, 2013
Last Update Posted : December 12, 2017
Sponsor:
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 Not Applicable

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
Drug Information available for: Vasopressin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: I
Vasopressin
Drug: vasopressin
vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
Placebo Comparator: 2
bolus of NS 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 ]

Secondary Outcome Measures :
  1. Secondary Objective is to Better Understand the Efficacy of Novel Endpoints of Resuscitation in the Management of Shock and the Ability of These Monitors to Predict Outcome After Trauma. [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 < 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 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 ClinicalTrials.gov identifier (NCT number): NCT00420407


Locations
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
Investigators
Principal Investigator: Stephen M. Cohn, MD The University of Texas Health Science Center at San Antonio

Additional Information:
Publications of Results:
Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00420407     History of Changes
Other Study ID Numbers: 056-1502-090
First Posted: January 11, 2007    Key Record Dates
Results First Posted: April 16, 2013
Last Update Posted: December 12, 2017
Last Verified: April 2013

Additional relevant MeSH terms:
Shock
Shock, Traumatic
Pathologic Processes
Wounds and Injuries
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs