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
Results First Received: September 11, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Conditions: Injuries
Shock, Traumatic
Interventions: Drug: normal saline control
Drug: vasopressin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
recruitment location - Emergency room Feb 2007- Feb 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
clinical indication prohibiting potential use of vasopressin.

Reporting Groups
  Description
Normal Saline

bolus of NS followed by continuous infusion of NS, no vasopressin added

normal saline control : no vasopressin added to bolus or 5 hour continuous infusion

Vasopressin

Vasopressin

vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours


Participant Flow:   Overall Study
    Normal Saline     Vasopressin  
STARTED     41     40  
COMPLETED     37     34  
NOT COMPLETED     4     6  
Lost to Follow-up                 0                 3  
Physician Decision                 2                 1  
subject identified as detainee                 1                 0  
subject identified as Jehovah's witness                 1                 0  
Withdrawal by Subject                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Vasopressin enrolled 40 and two withdrawn and never received drug (38) Normal saline enrolled 41 and one withdrawn and never received drug (40)

Reporting Groups
  Description
Normal Saline

bolus of NS followed by continuous infusion of NS, no vasopressin added

normal saline control : no vasopressin added to bolus or 5 hour continuous infusion

Vasopressin

Vasopressin

vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours

Total Total of all reporting groups

Baseline Measures
    Normal Saline     Vasopressin     Total  
Number of Participants  
[units: participants]
  41     40     81  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     35     35     70  
>=65 years     6     5     11  
Age  
[units: years]
Mean ± Standard Deviation
  46.3  ± 26.1     48.1  ± 19.8     47.1  ± 20.4  
Gender  
[units: participants]
     
Female     7     11     18  
Male     34     29     63  
Region of Enrollment  
[units: participants]
     
United States     41     40     81  



  Outcome Measures

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

2.  Secondary:   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 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Stephen Cohn, M.D.
Organization: University of Texas Health Science Center at San Antonio
phone: 210-567-5724
e-mail: mccarthyj@uthscsa.edu


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
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