Serum Vasopressin Levels and Severe Hemorrhagic Shock

Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01676454
• Other study ID #: Vasopressin Study
• Status: Withdrawn
• Start date: November 2012
• Est. completion date: January 2013

Study information

• Verified date: May 2018
• Source: Poudre Valley Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with a minor injury or injuries, defined as:

1. no episodes of systolic blood pressure < 90 mmHg between occurrence of injury and admission;

2. no blood transfusion requirement;

3. base deficit < 5 mEq/L;

4. no requirement for mechanical ventilation other than transiently during orthopedic surgery.

Exclusion Criteria:

1. Pregnancy

2. corticosteroid use,

3. prisoners, and/or

4. head trauma as determined by computed tomography (head trauma may itself induce diabetes insipidus, a marker of pituitary damage and vasopressin deficiency), and/or

5. evidence of spinal cord injury (another cause of vasodilatory shock).

Patients will also be excluded if pre-hospital provider information cannot be obtained, or indicates that the trauma occurred more than one 1 hour prior to emergency department admission.

Related Conditions & MeSH terms

• Injury
• Shock, Hemorrhagic

Locations

Country	Name	City	State
United States	Medical Center of the Rockies	Loveland	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Poudre Valley Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum vasopressin levels.	6 mL's per blood draw for 5 timepoints=30 mL's total blood drawn.	24 hours.

External Links

•   System website