Clinical trial NCT00753402: The Effects of Epinephrine in Endotoxemia in Normal Volunteers
Official title: The Effects of Epinephrine in Endotoxemia in Normal Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune System
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2008-09-16
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Physiological, Hematological, Immunological Responses
timeFrame: 0.5-24 hrs post Endotoxin administration
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers-RWJMS
state: New Jersey
Study officials:
affiliation: Rutgers-RWJMS
name: Siobhan Corbett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Matot I, Paskaleva R, Eid L, Cohen K, Khalaileh A, Elazary R, Keidar A. Effect of the volume of fluids administered on intraoperative oliguria in laparoscopic bariatric surgery: a randomized controlled trial. Arch Surg. 2012 Mar;147(3):228-34. doi: 10.1001/archsurg.2011.308. Epub 2011 Nov 21.
citation: Jan BU, Coyle SM, Oikawa LO, Lu SE, Calvano SE, Lehrer PM, Lowry SF. Influence of acute epinephrine infusion on endotoxin-induced parameters of heart rate variability: a randomized controlled trial. Ann Surg. 2009 May;249(5):750-6. doi: 10.1097/SLA.0b013e3181a40193.