Back to resultsLow Dose Vasopressin in Traumatic Shock
Primary Purpose
Injuries, Shock, Traumatic
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
normal saline control
vasopressin
Sponsored by
About this trial
This is an interventional treatment trial for Injuries
Eligibility 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 (systolic blood pressure) < 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 (cardiopulmonary resucitation) 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);
Sites / Locations
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
I
2
Arm Description
Vasopressin
bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added
Outcomes
Primary Outcome Measures
The Primary Endpoint of This Study Will be Day 30 Mortality.
Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.
Secondary Outcome Measures
Level of Vasopressin After Trauma.
Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm
Full Information
NCT ID
NCT00420407
First Posted
January 9, 2007
Last Updated
June 6, 2019
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT00420407
Brief Title
Low Dose Vasopressin in Traumatic Shock
Official Title
Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose Vasopressin Versus Placebo in Traumatic Shock Resuscitation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Why Stopped
accrual rate
Study Start Date
February 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Injuries, Shock, Traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Arm Description
Vasopressin
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
bolus of NS (normal saline) followed by continuous infusion of NS, no vasopressin added
Intervention Type
Drug
Intervention Name(s)
normal saline control
Intervention Description
no vasopressin added to bolus or 5 hour continuous infusion
Intervention Type
Drug
Intervention Name(s)
vasopressin
Intervention Description
vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours
Primary Outcome Measure Information:
Title
The Primary Endpoint of This Study Will be Day 30 Mortality.
Description
Survival of a traumatic injury subject to at least 30 days after admission to the emergency room.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Level of Vasopressin After Trauma.
Description
Level of vasopressin 12 hours after infusion was measured for all subjects in vasopressin arm
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 (systolic blood pressure) < 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 (cardiopulmonary resucitation) 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);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen M. Cohn, MD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21161222
Citation
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.
Results Reference
result
Links:
URL
http://www.surgery.uthscsa.edu/
Description
Department of Surgery Web Page, Vasopressin presentation
Learn more about this trial
Low Dose Vasopressin in Traumatic Shock
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