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Completed

NCT Number: NCT00753402

The Effects of Epinephrine in Endotoxemia in Normal Volunteers

Epinephrine (adrenaline) is a substance produced by the body (in the adrenal gland) in response to stress such as infection or injury. 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 give epinephrine before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by 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, 08901, United States

About this study

The body's immune response to injury otr infection is very complex. immune cell activity, the release of specific mediators (such as proteins), genetics (Deoxyribonucleic acid or DNA) and/or the body's "instructions" for making proteins (Ribonucleic Acid or RNA) may effect the body's clinical response to a stress such as an infection.Epinephrine (adrenaline) is a substance produced by the body (in the adrenal gland)in response to stress such as infection or injury. 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 give epinephrine before and/or after endotoxin to determine if this medication can prevent or relieve any of the symptoms caused by endotoxin.In addition, this study may determine whether any of the above(proteins,DNA,RNA,etc.) correlate with or affect the body's response to epinephrine and/or endotoxin. This will enable the investigator to better understand whether treatment with this substance can alter the body's immune response.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • General good health as demonstrated by medical history, physical& laboratory tests
  • Age between 18 and 40 years
  • Written informed consent prior to the performance of any study related procedures

Exclusion criteria

  • History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension
  • Any medication taken in past 48 hrs (except birth control)
  • Recent history of alcohol or drug abuse
  • Unable to provide written informed consent
  • Exposure to any experimental agent or procedure within 30 days of study
  • Pregnant or breast-feeding

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

Endotoxin, Epinephrine

Biological

Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes/Epinephrine 30mcg/kg/min

Other names: Adrenaline Chloride

Primary outcomes

  1. Physiological, Hematological, Immunological Responses

    Time frame: 0.5-24 hrs post Endotoxin administration

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Acronym: Epi

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2008
Registry last updated
May 27, 2015

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.

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