Inflammation and the Host Response to Injury (In Healthy Volunteers) - Full Text View

Sponsored by:	University of Medicine and Dentistry New Jersey
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00820989

Purpose

The body's immune response to injury or infection is very complex.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether certain proteins, genetics, or heart rate variability change affects the body's response to endotoxin.

Condition	Intervention	Phase
Immune System	Biological: Endotoxin, Lipopolysaccharide, LPS	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title:	Inflammation and the Host Response to Injury (In Healthy Volunteers)

Further study details as provided by University of Medicine and Dentistry New Jersey:

Primary Outcome Measures:

Physiological, Hematological, Immunological Responses [ Time Frame: .5-24 hours after Endotoxin administration ] [ Designated as safety issue: No ]

Estimated Enrollment:	170
Study Start Date:	February 2000
Estimated Study Completion Date:	February 2020
Estimated Primary Completion Date:	February 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Time points after IV Endotoxin administration compared to baseline (immediately before Endotoxin administration).	Biological: Endotoxin, Lipopolysaccharide, LPS Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes)

Detailed Description:

The body's immune response to injury or infection is very complex.Immune cell activity, the release of specific mediators(such as proteins, genetics(Deoxyribonucleic acid or DNA), the body's "instructions" for making proteins (Ribonucleic Acid or RNA) and heart rate variability (HRV,the intervals between heartbeats) may affect the body's clinical response to stress such as infection.Endotoxin is a man-made substance, which causes the body to "mimic" sickness (fever,chills, and achiness)for a few hours. This study is designed to determine whether any of the above (proteins,genetics,or HRV, etc.) correlate with or affect the body's response to endotoxin.This will enable the investigator to better understand the mechanisms involved in the immune response as well as potential therapeutic strategies to improve outcomes in patients.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Good general health as demonstrated by medical history,physical exam, and laboratory tests within 6 weeks of study.
Written informed consent prior to the performance of any study related procedure.

Exclusion Criteria:

History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
Recent history of alcohol or drug abuse
Mental capacity limited to the extent that the subject cannot provide written informed consent or information regarding treatment-emergent adverse events and/or tolerance of study medication and/or study procedures
Exposure to any experimental agent or procedure within 30 days of study
Pregnancy or breast feeding
Prior exposure to endotoxin in an experimental setting -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820989

Contacts

Contact: Susette M Coyle, RN	732-235-8143	coylesu@umdnj.edu
Contact: Marie A Macor, RN	732-235-8143	macorma@umdnj.edu

Locations

United States, New Jersey
UMDNJ-RWJMS	Recruiting
New Brunswick, New Jersey, United States, 08850

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

Investigators

Principal Investigator:

Stephen F Lowry, MD

UMDNJ-RWJMS

More Information

No publications provided

Responsible Party:	UMDNJ-RWJMS ( Stephen F. Lowry, MD )
Study ID Numbers:	0220013432, GM64351-01
Study First Received:	January 9, 2009
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00820989 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Medicine and Dentistry New Jersey:

Healthy Immune System

Study placed in the following topic categories:

Healthy
Inflammation

Additional relevant MeSH terms:

Pathologic Processes
Inflammation

ClinicalTrials.gov processed this record on May 06, 2009