Vasopressin Deficiency in Hemorrhagic Shock
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| First Received Date ICMJE | April 19, 2010 | ||||
| Last Updated Date | March 7, 2012 | ||||
| Start Date ICMJE | February 2010 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01107314 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vasopressin Deficiency in Hemorrhagic Shock | ||||
| Official Title ICMJE | Vasopressin Deficiency in Hemorrhagic Shock | ||||
| Brief Summary | In this study we hope to delineate the typical vasoactive mediator response of trauma patients to shock. We plan to assess serum levels of vasopressin and also catecholamines, angiotensin, and cortisol during resuscitation of trauma patients to delineate high risk populations for vasopressin deficiency. |
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| Detailed Description | This is a prospective observational study. The only research-driven procedure will be the removal of blood samples at designated time points(total blood removed 48 cc per patient). Hemodynamic, fluid infusion and agitation/pain data (RAMSEY Score) will prospectively be collected for research purposes. We will collect data from a convenience sample of patients (when research staff is available) over a one year period. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | observational study - trauma patients admitted to University Hospital |
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| Condition ICMJE | Body Response to Trauma | ||||
| Intervention ICMJE | Other: Phlebotomy
Blood draws (total 48 cc blood) |
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| Study Group/Cohort (s) | trauma patient
SBP less than 90mmHg
Intervention: Other: Phlebotomy |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 81 | ||||
| Completion Date | April 2011 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| 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 | NCT01107314 | ||||
| Other Study ID Numbers ICMJE | 2009-0528-H, A-13969.2 | ||||
| Has Data Monitoring Committee | No | ||||
| 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 |
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| Information Provided By | The University of Texas Health Science Center at San Antonio | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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