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OpenTrials
Completed

NCT Number: NCT00820989

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rutgers-RWJMS

New Brunswick, New Jersey, 08850, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 -

Treatment and study plan

Endotoxin, Lipopolysaccharide, LPS

Biological

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

Other names: Sodium Chloride Solution

Primary outcomes

  1. Physiological, Hematological, Immunological Responses

    Time frame: .5-24 hours after Endotoxin administration

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Acronym: Mono

Important dates

Study start
2000
Primary completion
2011
Study completion
2011
First posted
Jan 12, 2009
Registry last updated
May 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.