Vasopressin Deficiency in Hemorrhagic Shock

In this study we hope to delineate the typical vasoactive mediator response of trauma patients to shock. We plan to assess serum levels of vasopressin and also catecholamines, angiotensin, and cortisol during resuscitation of trauma patients to delineate high risk populations for vasopressin deficiency.

Study Overview

• Status: Completed
• Conditions: Body Response to Trauma
• Intervention / Treatment: Other: Phlebotomy

Detailed Description

This is a prospective observational study. The only research-driven procedure will be the removal of blood samples at designated time points(total blood removed 48 cc per patient). Hemodynamic, fluid infusion and agitation/pain data (RAMSEY Score) will prospectively be collected for research purposes. We will collect data from a convenience sample of patients (when research staff is available) over a one year period.

• Study Type: Observational
• Enrollment (Actual): 81

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229-3900
      • UTHSCSA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

observational study - trauma patients admitted to University Hospital

Description

Inclusion Criteria:

• Patient is a male or female patient presumed to be at least 18 years of age;
• Patient has a reported or actual systolic blood pressure < 90 mmHg within 1 hour of arrival to the Emergency Room;
• Patient has clinical evidence of acute traumatic injury;

Exclusion Criteria:

• Patient is asystolic or requires CPR prior to arrival;
• Patient was transferred from an outside facility
• Patient known to be pregnant
• Patient known to be prisoner

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
trauma patient; SBP less than 90mmHg	Other: Phlebotomy; Blood draws (total 48 cc blood)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: Stephen M Cohn, MD, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): April 30, 2011
• Study Completion (Actual): April 30, 2011

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimate): April 20, 2010

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 12, 2018
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Hemorrhage; Shock; Pituitary Diseases; Diabetes Insipidus; Shock, Hemorrhagic; Diabetes Insipidus, Neurogenic
• Other Study ID Numbers: 2009-0528-H; A-13969.2 (Other Grant/Funding Number: DoD)