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

Phase 1

Completed

• Conditions: Immune System
• Interventions: Biological: Endotoxin, Lipopolysaccharide, LPS

• Registration Number: NCT00820989
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

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 Timeline

• Study Start: 2000-02
• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Endotoxin, Lipopolysaccharide, LPS	Time points after IV Endotoxin administration compared to baseline (immediately before Endotoxin administration).

Primary Outcome Measures

Name	Time	Method
Physiological, Hematological, Immunological Responses	.5-24 hours after Endotoxin administration

Trial Locations

Locations (1)

Rutgers-RWJMS; 🇺🇸 New Brunswick, New Jersey, United States