Low Dose Vasopressin in Traumatic Shock

This study has been terminated.
(accrual rate)
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00420407
First received: January 9, 2007
Last updated: April 16, 2013
Last verified: April 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 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
Study First Received: January 9, 2007
Results First Received: September 11, 2012
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014