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Trials / Withdrawn

WithdrawnNCT01676454

Serum Vasopressin Levels and Severe Hemorrhagic Shock

Determination of Serum Vasopressin Levels and Correlation With Life-threatening Complications in Adults With Severe Hemorrhagic Shock.

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
Poudre Valley Health System · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to determine if vasopressin is used up by the body during traumatic shock (severe low blood pressure due to trauma).

Detailed description

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.

Conditions

Timeline

Start date
2012-11-01
Primary completion
2013-01-01
Completion
2013-01-01
First posted
2012-08-31
Last updated
2018-05-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01676454. Inclusion in this directory is not an endorsement.