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Vasopressin Deficiency in Hemorrhagic Shock

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ClinicalTrials.gov Identifier: NCT01107314
Recruitment Status : Completed
First Posted : April 20, 2010
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Body Response to Trauma 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 Design

Study Type : Observational
Actual Enrollment : 81 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Vasopressin Deficiency in Hemorrhagic Shock
Study Start Date : February 2010
Primary Completion Date : April 30, 2011
Study Completion Date : April 30, 2011

Groups and Cohorts

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

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 98 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
observational study - trauma patients admitted to University Hospital

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01107314

United States, Texas
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Principal Investigator: Stephen M Cohn, MD The University of Texas Health Science Center at San Antonio
More Information

Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT01107314     History of Changes
Other Study ID Numbers: 2009-0528-H
A-13969.2 ( Other Grant/Funding Number: DoD )
First Posted: April 20, 2010    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: March 2012

Additional relevant MeSH terms:
Diabetes Insipidus, Neurogenic
Diabetes Insipidus
Shock, Hemorrhagic
Pathologic Processes
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Arginine Vasopressin
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs