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

NCT ID: NCT00820989

Last Updated: 2014-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-02-29
• Study Completion Date: 2011-02-28

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.

Conditions

Immune System

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

A

Time points after IV Endotoxin administration compared to baseline (immediately before Endotoxin administration).

Group Type: EXPERIMENTAL

Endotoxin, Lipopolysaccharide, LPS

Intervention Type: BIOLOGICAL

Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (\~5 minutes)

Interventions

Endotoxin, Lipopolysaccharide, LPS

Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (\~5 minutes)

Intervention Type: BIOLOGICAL

Other Intervention Names

Sodium Chloride Solution

Eligibility 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 -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Siobhan Corbett, MD

Role: PRINCIPAL_INVESTIGATOR

Rutgers-RWJMS

Locations

Rutgers-RWJMS

New Brunswick, New Jersey, United States

Countries

United States

Other Identifiers

GM64351-01

Identifier Type: -

Identifier Source: secondary_id

0220013432

Identifier Type: -

Identifier Source: org_study_id