Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-11 @ 12:42 AM
Study NCT ID:
NCT03940651
Status:
TERMINATED
Last Update Posted:
2021-02-05
First Post:
2019-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac and Renal Biomarkers in Arthroplasty Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}, {'id': 'D018681', 'term': 'Anesthetics, General'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Funding ended', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2019-04-03', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2021-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively', 'timeFrame': 'Before discharge (approximately 24 hours after surgery)', 'description': 'Hs-cTnI increase \\>50% above the sex-specific 99th percentile upper reference limit'}, {'measure': 'Incidence of myocardial injury defined by new Hs-cTnI elevation postoperatively', 'timeFrame': 'at time of postoperative visit (around 2 weeks post discharge)', 'description': 'Hs-cTnI increase \\>50% above the sex-specific 99th percentile upper reference limit'}, {'measure': 'Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population', 'timeFrame': 'Before discharge (approximately 24 hours after surgery)', 'description': 'cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values'}, {'measure': 'Investigate the effect of spinal anesthesia on biomarker levels in hip arthroplasty population', 'timeFrame': 'at time of postoperative visit (around 2 weeks post discharge)', 'description': 'cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values'}, {'measure': 'Investigate the effect of spinal anesthesia on biomarker levels in knee arthroplasty population', 'timeFrame': 'at time of postoperative visit (around 2 weeks post discharge)', 'description': 'cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values'}, {'measure': 'Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population', 'timeFrame': 'Before discharge (approximately 24 hours after surgery)', 'description': 'cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values'}, {'measure': 'Investigate the effect of general anesthesia on biomarker levels in hip arthroplasty population', 'timeFrame': 'at time of postoperative visit (around 2 weeks post discharge)', 'description': 'cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values'}, {'measure': 'Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population', 'timeFrame': 'Before discharge (approximately 24 hours after surgery)', 'description': 'cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values'}, {'measure': 'Investigate the effect of general anesthesia on biomarker levels in knee arthroplasty population', 'timeFrame': 'at time of postoperative visit (around 2 weeks post discharge)', 'description': 'cardiovascular effect measured by changes in levels of Hs-cTnI postoperatively compared to baseline values'}, {'measure': 'Incidence of postoperative renal injury using investigational renal biomarkers', 'timeFrame': 'Before discharge (approximately 24 hours after surgery)', 'description': 'MIOX, Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL) and Nephrocheck measured in ng/ml'}, {'measure': 'Incidence of postoperative renal injury using investigational renal biomarkers', 'timeFrame': 'at time of postoperative visit (around 2 weeks post discharge)', 'description': 'MIOX, Kidney Injury Molecule-1 (KIM-1), Neutrophil gelatinase-associated lipocalin (NGAL) and Nephrocheck measured in ng/ml'}], 'secondaryOutcomes': [{'measure': 'Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension', 'timeFrame': 'before discharge', 'description': 'Pain score assessment using the visual analog score'}, {'measure': 'Difference renal biomarkers levels according to anesthesia groups - Pain scores and the incidence of intraoperative hypotension', 'timeFrame': 'at time of postoperative visit (around 2 weeks post discharge)', 'description': 'Pain score assessment using the visual analog score'}, {'measure': 'Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension', 'timeFrame': 'before discharge', 'description': 'Pain medication consumption measured in mg'}, {'measure': 'Difference renal biomarkers levels according to anesthesia groups - Pain medication consumption and the incidence of intraoperative hypotension', 'timeFrame': 'at time of postoperative visit (around 2 weeks post discharge)', 'description': 'Pain medication consumption measured in mg'}, {'measure': 'Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension', 'timeFrame': 'before discharge and at time of postoperative visit (around 2 weeks post discharge)', 'description': 'Pain score assessment using the visual analog score'}, {'measure': 'Difference in cardiac biomarker levels according to surgical groups - Pain scores, pain medications consumption and the incidence of intraoperative hypotension', 'timeFrame': 'before discharge', 'description': 'Pain score assessment using the visual analog score'}, {'measure': 'Difference in cardiac biomarker levels according to surgical groups - Pain scores and the incidence of intraoperative hypotension', 'timeFrame': 'at time of postoperative visit (around 2 weeks post discharge)', 'description': 'Pain score assessment using the visual analog score'}, {'measure': 'Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension', 'timeFrame': 'before discharge', 'description': 'Pain medication consumption measured in mg'}, {'measure': 'Difference in renal biomarker levels according to surgical groups - Pain medication consumption and the incidence of intraoperative hypotension', 'timeFrame': 'at time of postoperative visit (around 2 weeks post discharge)', 'description': 'Pain medication consumption measured in mg'}, {'measure': 'The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension', 'timeFrame': 'before discharge', 'description': 'Pain score assessment using the visual analog score'}, {'measure': 'The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain scores and the incidence of intraoperative hypotension', 'timeFrame': 'at time of postoperative visit (around 2 weeks post discharge)', 'description': 'Pain score assessment using the visual analog score'}, {'measure': 'The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension', 'timeFrame': 'before discharge', 'description': 'Pain medication consumption measured in mg'}, {'measure': 'The effect of nonsteroidal anti-inflammatory drugs (NSAIDs) on renal biomarkers - Pain medication consumption and the incidence of intraoperative hypotension', 'timeFrame': 'at time of postoperative visit (around 2 weeks post discharge)', 'description': 'Pain medication consumption measured in mg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Injury', 'Anesthesia', 'Myocardial Injury', 'Arthropathy of Knee', 'Arthropathy of Hip']}, 'referencesModule': {'references': [{'pmid': '17403800', 'type': 'BACKGROUND', 'citation': 'Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.'}, {'pmid': '23011713', 'type': 'BACKGROUND', 'citation': 'Cram P, Lu X, Kates SL, Singh JA, Li Y, Wolf BR. Total knee arthroplasty volume, utilization, and outcomes among Medicare beneficiaries, 1991-2010. JAMA. 2012 Sep 26;308(12):1227-36. doi: 10.1001/2012.jama.11153.'}, {'pmid': '25029449', 'type': 'BACKGROUND', 'citation': 'Khan J, Alonso-Coello P, Devereaux PJ. Myocardial injury after noncardiac surgery. Curr Opin Cardiol. 2014 Jul;29(4):307-11. doi: 10.1097/HCO.0000000000000069.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will compare the effect of spinal anesthesia to general anesthesia on the level of high sensitivity cardiac biomarkers in patients undergoing hip or knee arthroplasty. The investigators will also measure renal biomarkers in urine to evaluate kidney injury in the postoperative period.', 'detailedDescription': 'The study will enroll a total of 140 adult patients undergoing hip or knee arthroplasty (equal numbers) at Barnes-Jewish-Hospital. These procedures will be randomized with 50% of the procedures performed under spinal anesthesia and 50% procedures performed under general anesthesia.\n\nPatients randomized to spinal anesthesia will receive sedation with dexmedetomidine up to 1 mcg/kg/min, and then add small dose of propofol (up to 50 mcg/kg/min) and fentanyl at the discretion of the anesthesia provider the Richmond Agitation and Sedation Scale (RASS) -2 to -3. Headphones to play music will be offered to patients undergoing spinal anesthesia to minimize the noise generated from the surgical intervention.\n\nThe investigators will study the effect of spinal anesthesia versus general anesthesia on cardiac biomarker levels in hip and knee arthroplasty population (levels of Hs-cTnI postoperatively compared to baseline values) Also, the incidence of postoperative renal injury using investigational renal biomarkers, Myo-Inositol Oxygenase (MIOX) and Nephrocheck'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients, age 60 years or older\n* Ability to provide informed consent\n* American Society of Anesthesiologists (ASA) classification II or higher\n\nExclusion Criteria:\n\n* Hip fracture procedures\n* Contraindications to neuraxial anesthesia per The American Society of Regional Anesthesia (ASRA) guidelines\n* Procedure anticipated duration is longer than expected planned spinal anesthesia duration'}, 'identificationModule': {'nctId': 'NCT03940651', 'briefTitle': 'Cardiac and Renal Biomarkers in Arthroplasty Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Effect of Spinal Versus General Anesthesia on Cardiac and Renal Biomarker Levels in Hip and Knee Arthroplasty Surgery', 'orgStudyIdInfo': {'id': '201812100'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Knee Arthroplasty', 'description': 'Surgery to replace the knee joint with prothetic joint', 'interventionNames': ['Drug: Spinal Anesthesia', 'Drug: General Anesthetics']}, {'type': 'EXPERIMENTAL', 'label': 'Hip Arthroplasty', 'description': 'Surgery to replace the hip joint with prothetic joint', 'interventionNames': ['Drug: Spinal Anesthesia', 'Drug: General Anesthetics']}], 'interventions': [{'name': 'Spinal Anesthesia', 'type': 'DRUG', 'description': 'Patients will be randomized to type of anesthesia', 'armGroupLabels': ['Hip Arthroplasty', 'Knee Arthroplasty']}, {'name': 'General Anesthetics', 'type': 'DRUG', 'description': 'Patients will be randomized to type of anesthesia', 'armGroupLabels': ['Hip Arthroplasty', 'Knee Arthroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Mohammad Helwani, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott', 'class': 'INDUSTRY'}, {'name': 'BioMérieux', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}