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

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ClinicalTrials.gov Identifier: NCT00820989
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : May 21, 2014
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : February 2000
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011
Arms and Interventions
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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 Name: Sodium Chloride Solution


Outcome Measures
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Primary Outcome Measures :
  1. Physiological, Hematological, Immunological Responses [ Time Frame: .5-24 hours after Endotoxin administration ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00820989


Locations
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United States, New Jersey
Rutgers-RWJMS
New Brunswick, New Jersey, United States, 08850
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Siobhan Corbett, MD Rutgers-RWJMS
More Information
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Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00820989    
Other Study ID Numbers: 0220013432
GM64351-01
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: May 2014
Keywords provided by Rutgers, The State University of New Jersey:
Healthy Immune System
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes