Low Dose Vasopressin in Traumatic Shock
This study has been terminated.
(accrual rate)
Sponsor:
The University of Texas Health Science Center at San Antonio
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
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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 Pathologic Processes Wounds and Injuries 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 May 19, 2013