The Effects of Epinephrine in Endotoxemia in Normal Volunteers
Epi
1 other identifier
interventional
37
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2008
CompletedFirst Posted
Study publicly available on registry
September 16, 2008
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedMay 27, 2015
May 1, 2015
Same day
September 15, 2008
May 26, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Physiological, Hematological, Immunological Responses
0.5-24 hrs post Endotoxin administration
Study Arms (2)
A
PLACEBO COMPARATORIV Endotoxin plus saline vehicle (placebo)
B
ACTIVE COMPARATORIV Endotoxin plus IV epinephrine
Interventions
Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (\~5 minutes)
Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (\~5 minutes/Epinephrine 30mcg/kg/min
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rutgers-RWJMS
New Brunswick, New Jersey, 08901, United States
Related Publications (2)
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.
PMID: 22106246DERIVEDJan 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.
PMID: 19387330DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Siobhan Corbett, MD
Rutgers-RWJMS
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2008
First Posted
September 16, 2008
Study Start
February 1, 2012
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
May 27, 2015
Record last verified: 2015-05