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Biomarker Analysis of Stress

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00527384
First Posted: September 10, 2007
Last Update Posted: April 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
  Purpose
Physiological changes can occur from different types of stress as induced by an infection, an environmental toxicant exposure, or an emotional disturbance. The stress-induced effects can modify health by lessening defense mechanisms as maintained by the immune system. The ability of different forms of stress to alter physiological processes (body functions) will be assessed by monitoring the blood profile of cell numbers and functions as well as the plasma protein content. It is anticipated that the pattern of blood changes will reflect the types of stress and the degree to which body functions could be altered by the stress.

Condition
Sepsis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Biomarker Signatures of Biological, Chemical, or Psychological Stress

Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Estimated Enrollment: 50
Study Start Date: October 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:
Blood will be collected from patients with an ongoing infection that has lead to sepsis (systemic inflammation) as a index of major stress. The blood will be analyzed for the types of proteins that could alter immune system functions and affect organ functions, including cardiovascular effects due to blood vessel changes. This will be followed by analysis of stress effects on mice and mice that have been generated with human immune cells. The ability of stress to alter blood patterns will also be examined in mice with genetic modification of metallothionein expression, which is believe to influence oxidative stress.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients at Wadsworth Center with Sepsis
  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): NCT00527384


Locations
United States, New York
Wadsworth Center
Albany, New York, United States, 12201
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Investigators
Principal Investigator: David A. Lawrence, Ph.D. Wadsworth Center
  More Information

ClinicalTrials.gov Identifier: NCT00527384     History of Changes
Other Study ID Numbers: 16014-CP-001
First Submitted: September 6, 2007
First Posted: September 10, 2007
Last Update Posted: April 14, 2015
Last Verified: April 2015

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
Stress