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
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 9, 2007 | ||||
| Last Updated Date | April 16, 2013 | ||||
| Start Date ICMJE | February 2007 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The Primary Endpoint of This Study Will be Day 30 Mortality. [ Time Frame: 30 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Our primary objective, therefore, is straightforward: to develop new resuscitation regimens that are beneficial in limiting organ dysfunction and mortality after severe injury | ||||
| Change History | Complete list of historical versions of study NCT00420407 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
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. | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Low Dose Vasopressin in Traumatic Shock | ||||
| Official Title ICMJE | Prospective, Randomized, Double-Blind, Multi-Center Trial of Low Dose Vasopressin Versus Placebo in Traumatic Shock Resuscitation | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 81 | ||||
| Completion Date | February 2011 | ||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: To be eligible for enrollment in the study, a patient must meet all of the follow criteria at assessment:
Exclusion Criteria: A patient meeting any one of the following criteria at hospital assessment is not eligible for enrollment:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00420407 | ||||
| Other Study ID Numbers ICMJE | 056-1502-090 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | The University of Texas Health Science Center at San Antonio | ||||
| Study Sponsor ICMJE | The University of Texas Health Science Center at San Antonio | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | The University of Texas Health Science Center at San Antonio | ||||
| Verification Date | April 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||