Clinical trial NCT01676454: Serum Vasopressin Levels and Severe Hemorrhagic Shock
Official title: Determination of Serum Vasopressin Levels and Correlation With Life-threatening Complications in Adults With Severe Hemorrhagic Shock.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Injury
Keywords: Vasopressin
Trauma
Injury
Lead sponsor: Poudre Valley Health System
Sponsor class: OTHER
First posted: 2012-08-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to Medical Center of the Rockies with minor injuries.

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.

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.

Primary outcomes:
measure: Serum vasopressin levels.
timeFrame: 24 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Loveland
country: United States
facility: Medical Center of the Rockies
state: Colorado
Study officials:
affiliation: Poudre Valley Health System
name: Julie Dunn, M.D.
role: PRINCIPAL_INVESTIGATOR
References: