Serum Vasopressin Levels and Severe Hemorrhagic Shock
|ClinicalTrials.gov Identifier: NCT01676454|
Recruitment Status : Withdrawn (Study closed without enrollment .)
First Posted : August 31, 2012
Last Update Posted : January 4, 2017
|Condition or disease|
For humans suffering trauma and severe hemorrhagic shock, no randomized controlled studies of the effect of exogenous vasopressin use exist, although case reports have suggested it may be of benefit. Even some moribund patients with "irreversible" shock survived severe hemorrhagic shock after administration of vasopressin. This suggests that at least some patients suffering severe trauma could benefit from AAVP administration. Recently, many clinicians and notable research consortiums have suggested that AVP shows promise for human resuscitation and have called for further human studies.
This is a prospective, single-center observational study designed to evaluate (1) whether vasopressin is depleted in severe, but not minor, trauma; and (2) the degree to which endogenous vasopressin levels predict the occurrence of ARDS, sepsis, or death. To test the first hypothesis, serum vasopressin levels (continuous independent variable) will be assessed at enrollment (time 0), 6, 12, 18, and 24 hours later, and correlated with the two levels of trauma (categorical dependent variable). To test the second hypothesis, serum vasopressin levels (now a continuous dependent variable) will be correlated with each of three outcomes-death, ARDS, and sepsis.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||Determination of Serum Vasopressin Levels and Correlation With Life-threatening Complications in Adults With Severe Hemorrhagic Shock.|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Cohort will consist of subjects with a minor injury or injuries defined as:
- Serum vasopressin levels. [ Time Frame: 24 hours. ]6 mL's per blood draw for 5 timepoints=30 mL's total blood drawn.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676454
|United States, Colorado|
|Medical Center of the Rockies|
|Loveland, Colorado, United States, 80538|
|Principal Investigator:||Julie Dunn, M.D.||Poudre Valley Health System|