Serum Vasopressin Levels and Severe Hemorrhagic Shock

NCT01676454 | Withdrawn

• 1 other identifier: Vasopressin Study
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Injury

Keywords

Vasopressin; Trauma; Injury

Outcome Measures

Primary Outcomes (1)

• Serum vasopressin levels.

  6 mL's per blood draw for 5 timepoints=30 mL's total blood drawn.

  24 hours.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with a minor injury or injuries, defined as:
• no episodes of systolic blood pressure \< 90 mmHg between occurrence of injury and admission;
• no blood transfusion requirement;
• base deficit \< 5 mEq/L;
• no requirement for mechanical ventilation other than transiently during orthopedic surgery.

You may not qualify if:

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

Sponsors & Collaborators

• Poudre Valley Health System: lead

Study Sites (1)

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Related Links

• System website

MeSH Terms

Conditions

Wounds and Injuries; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Julie Dunn, M.D.

  Poudre Valley Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2012
• First Posted: August 31, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 25, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)