Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:40 AM
Study NCT ID:
NCT00753402
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2008-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Epinephrine in Endotoxemia in Normal Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2017-03-15', 'releaseDate': '2017-01-26'}, {'resetDate': '2017-04-27', 'releaseDate': '2017-03-17'}], 'estimatedResultsFirstSubmitDate': '2017-01-26'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D004731', 'term': 'Endotoxins'}, {'id': 'D008070', 'term': 'Lipopolysaccharides'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011135', 'term': 'Polysaccharides, Bacterial'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D000942', 'term': 'Antigens, Bacterial'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2008-09-15', 'studyFirstSubmitQcDate': '2008-09-15', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiological, Hematological, Immunological Responses', 'timeFrame': '0.5-24 hrs post Endotoxin administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Immune System']}, 'referencesModule': {'references': [{'pmid': '22106246', 'type': 'DERIVED', '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.'}, {'pmid': '19387330', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General good health as demonstrated by medical history, physical\\& laboratory tests\n* Age between 18 and 40 years\n* Written informed consent prior to the performance of any study related procedures\n\nExclusion Criteria:\n\n* History of cancer, rheumatoid arthritis, or immunological, renal, hepatic, endocrine, neurologic, heart disease or hypertension\n* Any medication taken in past 48 hrs (except birth control)\n* Recent history of alcohol or drug abuse\n* Unable to provide written informed consent\n* Exposure to any experimental agent or procedure within 30 days of study\n* Pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT00753402', 'acronym': 'Epi', 'briefTitle': 'The Effects of Epinephrine in Endotoxemia in Normal Volunteers', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'The Effects of Epinephrine in Endotoxemia in Normal Volunteers', 'orgStudyIdInfo': {'id': '0220003283'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'description': 'IV Endotoxin plus saline vehicle (placebo)', 'interventionNames': ['Biological: Endotoxin, Lipopolysaccharide, LPS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'IV Endotoxin plus IV epinephrine', 'interventionNames': ['Biological: Endotoxin, Lipopolysaccharide, LPS', 'Biological: Endotoxin, Epinephrine']}], 'interventions': [{'name': 'Endotoxin, Lipopolysaccharide, LPS', 'type': 'BIOLOGICAL', 'otherNames': ['Sodium Chloride Solution'], 'description': 'Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (\\~5 minutes)', 'armGroupLabels': ['A', 'B']}, {'name': 'Endotoxin, Epinephrine', 'type': 'BIOLOGICAL', 'otherNames': ['Adrenaline Chloride'], 'description': 'Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (\\~5 minutes/Epinephrine 30mcg/kg/min', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers-RWJMS', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}], 'overallOfficials': [{'name': 'Siobhan Corbett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers-RWJMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2017-01-26', 'type': 'RELEASE'}, {'date': '2017-03-15', 'type': 'RESET'}, {'date': '2017-03-17', 'type': 'RELEASE'}, {'date': '2017-04-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Rutgers, The State University of New Jersey'}}}}