Mono: Inflammation and the Host Response to Injury (In Healthy Volunteers)

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Completed

CT.gov ID

NCT00820989

Collaborator

(none)

116

Enrollment

Location

Arm

132

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Immune System	Biological: Endotoxin, Lipopolysaccharide, LPS	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

116 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Inflammation and the Host Response to Injury (In Healthy Volunteers)

Study Start Date :

Feb 1, 2000

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A 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) Other Names: Sodium Chloride Solution

Arm

Intervention/Treatment

Experimental: A

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)

Other Names:

Sodium Chloride Solution

Outcome Measures

Primary Outcome Measures

Physiological, Hematological, Immunological Responses [.5-24 hours after Endotoxin administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Rutgers-RWJMS	New Brunswick	New Jersey	United States	08850

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Investigators

Principal Investigator: Siobhan Corbett, MD, Rutgers-RWJMS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rutgers, The State University of New Jersey

ClinicalTrials.gov Identifier:

NCT00820989

Other Study ID Numbers:

0220013432
GM64351-01

First Posted:

Jan 12, 2009

Last Update Posted:

May 21, 2014

Last Verified:

May 1, 2014

Keywords provided by Rutgers, The State University of New Jersey

Healthy Immune System

Additional relevant MeSH terms:

Inflammation

Study Results

No Results Posted as of May 21, 2014