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Serum Vasopressin Levels and Severe Hemorrhagic Shock

This study has been withdrawn prior to enrollment.
(Principal investigator primary site closed; this site is closing down our portion of the study as a result.)
Sponsor:
Information provided by (Responsible Party):
Julie Dunn, M.D., Poudre Valley Health System
ClinicalTrials.gov Identifier:
NCT01676454
First received: August 21, 2012
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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).


Condition
Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of Serum Vasopressin Levels and Correlation With Life-threatening Complications in Adults With Severe Hemorrhagic Shock.

Resource links provided by NLM:


Further study details as provided by Poudre Valley Health System:

Primary Outcome Measures:
  • Serum vasopressin levels. [ Time Frame: 24 hours. ] [ Designated as safety issue: No ]
    6 mL's per blood draw for 5 timepoints=30 mL's total blood drawn.


Enrollment: 0
Study Start Date: November 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to Medical Center of the Rockies with minor injuries.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01676454

Locations
United States, Colorado
Medical Center of the Rockies
Loveland, Colorado, United States, 80538
Sponsors and Collaborators
Poudre Valley Health System
Investigators
Principal Investigator: Julie Dunn, M.D. Poudre Valley Health System
  More Information

Additional Information:
No publications provided

Responsible Party: Julie Dunn, M.D., Principal Investigator, Poudre Valley Health System
ClinicalTrials.gov Identifier: NCT01676454     History of Changes
Other Study ID Numbers: Vasopressin Study
Study First Received: August 21, 2012
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Poudre Valley Health System:
Vasopressin
Trauma
Injury

Additional relevant MeSH terms:
Shock, Hemorrhagic
Hemorrhage
Pathologic Processes
Shock
Arginine Vasopressin
Vasopressins
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on November 25, 2014