Vasopressin Deficiency in Hemorrhagic Shock

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT01107314
First received: April 19, 2010
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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 Intervention
Body Response to Trauma
Other: Phlebotomy

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Vasopressin Deficiency in Hemorrhagic Shock

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at San Antonio:

Enrollment: 81
Study Start Date: February 2010
Study Completion Date: April 2011
Groups/Cohorts Assigned Interventions
trauma patient
SBP less than 90mmHg
Other: Phlebotomy
Blood draws (total 48 cc blood)

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.

  Eligibility

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

observational study - trauma patients admitted to University Hospital

Criteria

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
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: NCT01107314

Locations
United States, Texas
UTHSCSA
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
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
  More Information

No publications provided

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
Study First Received: April 19, 2010
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Shock, Hemorrhagic
Diabetes Insipidus
Diabetes Insipidus, Neurogenic
Hemorrhage
Pathologic Processes
Shock
Kidney Diseases
Urologic Diseases
Pituitary Diseases
Endocrine System Diseases
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014