Serum Vasopressin Levels and Severe Hemorrhagic Shock

NCT ID: NCT01676454

Last Updated: 2018-05-25

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-01-31

Brief 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

Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Vasopressin levels.

Cohort will consist of subjects 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.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poudre Valley Health System

OTHER

Sponsor Role: lead

Responsible Party

Julie Dunn, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie Dunn, M.D.

Role: PRINCIPAL_INVESTIGATOR

Poudre Valley Health System

Locations

Medical Center of the Rockies

Loveland, Colorado, United States

Countries

United States

Related Links

http://pvhs.org/research

System website

Other Identifiers

Vasopressin Study

Identifier Type: -

Identifier Source: org_study_id