Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT03431532
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2018-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monocyte Subsets Altered by Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2015-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-10', 'studyFirstSubmitDate': '2018-01-30', 'studyFirstSubmitQcDate': '2018-02-11', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CD 14 and HLA-DR Expression Patterns on monocytes', 'timeFrame': '1 year', 'description': 'CD 14 and HLA-DR Expression Patterns on monocytes in whole blood culture assay'}], 'secondaryOutcomes': [{'measure': 'Intracellular TNF-alpha production', 'timeFrame': '1 year', 'description': 'Intracellular TNF-alpha production in whole blood culture assay'}, {'measure': 'TNF-alpha and IL-10 release', 'timeFrame': '1 year', 'description': 'TNF-alpha and IL-10 release in whole blood culture assay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anesthesia', 'general anesthesia', 'neuraxial anesthesia', 'monocyte funtion', 'CD 14, HLA-DR', 'Interleukines'], 'conditions': ['Regional Anesthesia', 'General Anesthesia', 'Immune Function']}, 'referencesModule': {'references': [{'pmid': '29094483', 'type': 'BACKGROUND', 'citation': 'Bomberg H, Volk T, Biedler A, Schneider SO. Impact of intraoperative blood salvage on monocyte subsets alteration and intracellular tumor necrosis factor-alpha production. J Biomed Mater Res A. 2018 Mar;106(3):815-821. doi: 10.1002/jbm.a.36281. Epub 2017 Nov 28.'}, {'pmid': '25294235', 'type': 'BACKGROUND', 'citation': 'Schneider SO, Rensing H, Hartmann L, Grundmann U, Volk T, Biedler A. Impact of intraoperatively salvaged and washed blood on stimulated cytokine release in vitro. Transfusion. 2014 Oct;54(10 Pt 2):2782-90. doi: 10.1111/trf.12781. Epub 2014 Oct 7.'}, {'pmid': '22571497', 'type': 'BACKGROUND', 'citation': 'Schneider SO, Biedler AE, Behmenburg F, Volk T, Rensing H. Impact of shed blood products on stimulated cytokine release in an in vitro model of transfusion. Acta Anaesthesiol Scand. 2012 Jul;56(6):724-9. doi: 10.1111/j.1399-6576.2012.02704.x. Epub 2012 May 9.'}, {'pmid': '19630915', 'type': 'BACKGROUND', 'citation': 'Schneider SO, Rensing H, Graber S, Kreuer S, Kleinschmidt S, Kreimeier S, Muller P, Mathes AM, Biedler AE. Impact of platelets and fresh frozen plasma in contrast to red cell concentrate on unstimulated and stimulated cytokine release in an in vitro model of transfusion. Scand J Immunol. 2009 Aug;70(2):101-5. doi: 10.1111/j.1365-3083.2009.02278.x.'}, {'pmid': '12411792', 'type': 'BACKGROUND', 'citation': 'Biedler AE, Schneider SO, Seyfert U, Rensing H, Grenner S, Girndt M, Bauer I, Bauer M. Impact of alloantigens and storage-associated factors on stimulated cytokine response in an in vitro model of blood transfusion. Anesthesiology. 2002 Nov;97(5):1102-9. doi: 10.1097/00000542-200211000-00011.'}]}, 'descriptionModule': {'briefSummary': 'The impact of different anesthetic techniques on the immune system remains unclear.\n\nAim of this ex vivo / in vitro study was to determine the effects of general and neuraxial anesthesia on monocyte subset alteration and the release of prototypical pro- and anti-inflammatory cytokines. Twenty patients undergoing total knee replacement surgery were randomly assigned to receive either general anesthesia (ITN) or combined spinal/epidural anesthesia (CSE). CD14 and HLA-DR expression patterns on monocytes and intracellular TNF-alpha production were quantified via flow cytometry. TNF-α and IL-10 release were measured via enzyme linked immunosorbent assay (ELISA).', 'detailedDescription': 'Numerous of factors affect the immunological response during surgery. Despite intensive research, the impact of different anesthetic techniques on the immune system remains unclear.\n\nAim of this ex vivo / in vitro study was to determine the effects of general and neuraxial anesthesia on monocyte subset alteration and the release of prototypical pro- and anti-inflammatory cytokines. Twenty patients undergoing total knee replacement surgery were randomly assigned to receive either general anesthesia (ITN) or combined spinal/epidural anesthesia (CSE). Samples of venous blood were taken from the patients before and after induction of anesthesia, immediately, 6 hours, 24 hours, and 48 hours after surgery. All blood samples were incubated in presence or absence of LPS (lipopolysaccharide; 1 µg/ml) for 24 hours. CD14 and HLA-DR expression patterns on monocytes and intracellular TNF-alpha production were quantified via flow cytometry. TNF-α and IL-10 release were measured via enzyme linked immunosorbent assay (ELISA).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Surgical patients ungergoing total knee replacement surgery in neuraxial or General aneshtesia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Total knee replacement surgery\n* 18 years or older\n\nExclusion Criteria:\n\n* clinical signs of infection,\n* neoplasia\n* treatment with immunomodulatory agents\n* any kind of immune mediated disease.'}, 'identificationModule': {'nctId': 'NCT03431532', 'briefTitle': 'Monocyte Subsets Altered by Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Universität des Saarlandes'}, 'officialTitle': 'Neuraxial Versus General Anesthesia for Total Knee Replacement Surgery - Are There Different Effects on the Immune System?', 'orgStudyIdInfo': {'id': 'NA vs GA Immunology'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'neuraxial anesthesia', 'description': 'Patients with total knee replacement surgery having neuraxial anesthesia along with the procedure.'}, {'label': 'general anesthesia', 'description': 'Patients with total knee replacement surgery having General anesthesia along with the procedure.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '66424', 'city': 'Homburg', 'state': 'Saarland', 'country': 'Germany', 'facility': 'Sven O. Schneider, MD', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}], 'overallOfficials': [{'name': 'Sven Schneider, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universität des Saarlandes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Saarland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}