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

May 20, 2014 updated by: Rutgers, The State University of New Jersey
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

116

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08850
        • Rutgers-RWJMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Physiological, Hematological, Immunological Responses
Time Frame: .5-24 hours after Endotoxin administration
.5-24 hours after Endotoxin administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

January 9, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Estimate)

May 21, 2014

Last Update Submitted That Met QC Criteria

May 20, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0220013432
  • GM64351-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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