Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT01399268
Status:
COMPLETED
Last Update Posted:
2017-07-31
First Post:
2011-07-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Steroids in Bilateral Total Knee Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006854', 'term': 'Hydrocortisone'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D015062', 'term': '11-Hydroxycorticosteroids'}, {'id': 'D006889', 'term': 'Hydroxycorticosteroids'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D015065', 'term': '17-Hydroxycorticosteroids'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JulesK@hss.edu', 'phone': '212.606.1206', 'title': 'Dr. Jules', 'organization': 'HSS'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'The study collected data for 30 days after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Steroid', 'description': 'Hydrocortisone 100 mg IV Q 8hrs x3\n\nHydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Saline IV Q8hr x3\n\nSaline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Decrease in IL6 Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Hydrocortisone 100 mg IV Q 8hrs x3\n\nHydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times'}, {'id': 'OG001', 'title': 'Control', 'description': 'Saline IV Q8hr x3\n\nSaline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times'}], 'classes': [{'categories': [{'measurements': [{'value': '359.4', 'groupId': 'OG000', 'lowerLimit': '300', 'upperLimit': '400'}, {'value': '381.6', 'groupId': 'OG001', 'lowerLimit': '300', 'upperLimit': '400'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours postoperative', 'unitOfMeasure': 'pg/ml', 'dispersionType': '99% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Desmosine Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Hydrocortisone 100 mg IV Q 8hrs x3\n\nHydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times'}, {'id': 'OG001', 'title': 'Control', 'description': 'Saline IV Q8hr x3\n\nSaline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'timeFrame': '24 hours postoperative', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected'}, {'type': 'SECONDARY', 'title': 'Blood Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Hydrocortisone 100 mg IV Q 8hrs x3\n\nHydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times'}, {'id': 'OG001', 'title': 'Control', 'description': 'Saline IV Q8hr x3\n\nSaline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times'}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'spread': '30', 'groupId': 'OG000'}, {'value': '102', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours postoperative', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Hydrocortisone 100 mg IV Q 8hrs x3\n\nHydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times'}, {'id': 'OG001', 'title': 'Control', 'description': 'Saline IV Q8hr x3\n\nSaline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '5', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Length of hospital stay, an expected average of 5 days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'In Hospital Infection Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Hydrocortisone 100 mg IV Q 8hrs x3\n\nHydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times'}, {'id': 'OG001', 'title': 'Control', 'description': 'Saline IV Q8hr x3\n\nSaline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Length of hospital stay, an expected average of 5 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Hydrocortisone 100 mg IV Q 8hrs x3\n\nHydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times'}, {'id': 'OG001', 'title': 'Control', 'description': 'Saline IV Q8hr x3\n\nSaline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Length of hospital stay, an expected average of 5 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ability to Ambulate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Steroid', 'description': 'Hydrocortisone 100 mg IV Q 8hrs x3\n\nHydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times'}, {'id': 'OG001', 'title': 'Control', 'description': 'Saline IV Q8hr x3\n\nSaline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Steroid', 'description': 'Hydrocortisone 100 mg IV Q 8hrs x3\n\nHydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times'}, {'id': 'FG001', 'title': 'Control', 'description': 'Saline IV Q8hr x3\n\nSaline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Steroid', 'description': 'Hydrocortisone 100 mg IV Q 8hrs x3\n\nHydrocortisone: Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times'}, {'id': 'BG001', 'title': 'Control', 'description': 'Saline IV Q8hr x3\n\nSaline: Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '64', 'spread': '7', 'groupId': 'BG000'}, {'value': '71', 'spread': '9', 'groupId': 'BG001'}, {'value': '67.5', 'spread': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-27', 'studyFirstSubmitDate': '2011-07-14', 'resultsFirstSubmitDate': '2017-03-23', 'studyFirstSubmitQcDate': '2011-07-20', 'lastUpdatePostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-27', 'studyFirstPostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Decrease in IL6 Level', 'timeFrame': '24 hours postoperative'}], 'secondaryOutcomes': [{'measure': 'Desmosine Level', 'timeFrame': '24 hours postoperative'}, {'measure': 'Blood Glucose', 'timeFrame': '24 hours postoperative'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Length of hospital stay, an expected average of 5 days'}, {'measure': 'In Hospital Infection Rate', 'timeFrame': 'Length of hospital stay, an expected average of 5 days'}, {'measure': 'Mortality', 'timeFrame': 'Length of hospital stay, an expected average of 5 days'}, {'measure': 'Ability to Ambulate', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bilateral total knee replacement', 'cytokine', 'desmosine'], 'conditions': ['Postoperative Inflammatory Response']}, 'referencesModule': {'references': [{'pmid': '35087332', 'type': 'DERIVED', 'citation': 'McLawhorn AS, Poultsides LA, Sakellariou VI, Kunze KN, Fields KG, Jules-Elysee K, Sculco TP. Low-Dose Perioperative Corticosteroids Can Be Administered Without Additional Morbidity in Patients Undergoing Bilateral Total Knee Replacement: A Retrospective Follow-up Study of a Randomized Controlled Trial. HSS J. 2022 Feb;18(1):48-56. doi: 10.1177/15563316211006098. Epub 2021 Apr 9.'}]}, 'descriptionModule': {'briefSummary': 'Inflammation related to cytokine release is known to occur with surgery. The cytokine IL6, a major marker of inflammation is known to increase during total joint replacement surgery. IL6 has been found to be elevated postoperatively in patients with hip fractures and has been linked to mental status changes and possibly other complications. It is known to lead to shock and participate in the inflammatory state seen in sepsis. High levels have further been linked to postoperative fever, confusion, symptoms of depression, acute respiratory distress syndrome (ARDS) and fat embolism syndrome (FES). Previously the investigators found that low dose steroids given in two doses in the initial perioperative period decreased the amount of IL6 released compared to placebo, but this was not sustained past 24 hours.\n\nDesmosine is a stable breakdown product of elastin from lung tissue that can be measured in urine samples. It is considered to be a marker of lung injury and is found to be elevated in patients with ARDS, congestive obstructive pulmonary disease and FES. Previously, the investigators have found that urine desmosine levels rise with bilateral total knee replacement compared to unilateral total knee replacement indicating possible lung injury.\n\nTherefore the investigators hypothesize:\n\nContinued low dose steroids given three times over a 24 hour period will:\n\n1. Significantly decrease peak IL6 cytokine release during bilateral total knee replacement and maintaining this reduction in IL6 beyond 24 hours.\n2. Decrease urinary desmosine levels, and hence be protective of lung injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for bilateral total knee replacement\n* Between 50-90 years of age\n\nExclusion Criteria:\n\n* Patients on steroid therapy\n* Patients that require stress-dose steroid pre-operatively\n* Patients that smoke\n* Patients that are diabetic\n* Patients younger than 50 or older than 90 years'}, 'identificationModule': {'nctId': 'NCT01399268', 'briefTitle': 'Steroids in Bilateral Total Knee Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Effect of Steroids Given Over 24 Hours on Cytokine Release and Urinary Desmosine Levels in Patients Undergoing Bilateral Total Knee Replacement', 'orgStudyIdInfo': {'id': 'HSS-28116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Steroid', 'description': 'Hydrocortisone 100 mg IV Q 8hrs x3', 'interventionNames': ['Drug: Hydrocortisone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Saline IV Q8hr x3', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Hydrocortisone', 'type': 'DRUG', 'description': 'Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times', 'armGroupLabels': ['Steroid']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Kethy Jules-Elysee, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}