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Low Dose Vasopressin in Traumatic Shock

This study has been terminated.
(accrual rate)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00420407
First Posted: January 11, 2007
Last Update Posted: December 12, 2017
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.
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
  Purpose
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 Intervention
Injuries Shock, Traumatic Drug: normal saline control Drug: vasopressin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • The Primary Endpoint of This Study Will be Day 30 Mortality. [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 81
Study Start Date: February 2007
Study Completion Date: February 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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);
  Contacts and Locations
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
  More Information

Additional Information:
Publications:
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 Submitted: January 9, 2007
First Posted: January 11, 2007
Results First Submitted: September 11, 2012
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