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

January 9, 2007
April 16, 2013
February 2007
April 2009   (final data collection date for primary outcome measure)
The Primary Endpoint of This Study Will be Day 30 Mortality. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Our primary objective, therefore, is straightforward: to develop new resuscitation regimens that are beneficial in limiting organ dysfunction and mortality after severe injury
Complete list of historical versions of study NCT00420407 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
Low Dose Vasopressin in Traumatic Shock
Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose Vasopressin Versus Placebo in Traumatic Shock Resuscitation

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Injuries
  • Shock, Traumatic
  • Drug: normal saline control
    no vasopressin added to bolus or 5 hour continuous infusion
  • Drug: vasopressin
    vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
  • Experimental: I
    Vasopressin
    Intervention: Drug: vasopressin
  • Placebo Comparator: 2
    bolus of NS followed by continuous infusion of NS, no vasopressin added
    Intervention: Drug: normal saline control
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
81
February 2011
April 2009   (final data collection date for primary outcome measure)

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);
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00420407
056-1502-090
Yes
The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
Not Provided
Principal Investigator: Stephen M. Cohn, MD The University of Texas Health Science Center at San Antonio
The University of Texas Health Science Center at San Antonio
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP