Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-01-06 @ 11:13 PM
Study NCT ID:
NCT04195360
Status:
UNKNOWN
Last Update Posted:
2019-12-13
First Post:
2019-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Incidence of Orthostatic Intolerance and Hypotension in Primary Unicompartmental Knee Arthroplasty (UKA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007024', 'term': 'Hypotension, Orthostatic'}, {'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D054969', 'term': 'Primary Dysautonomias'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2019-12-02', 'studyFirstSubmitQcDate': '2019-12-10', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain score during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured by verbal rating scale (VRS) from 0 to 10'}, {'measure': 'Estimated bleeding', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mL'}, {'measure': 'Opioid usage', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mg'}, {'measure': 'Cumulative fluid administration and losses', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mL'}], 'primaryOutcomes': [{'measure': 'Incidence of orthostatic intolerance', 'timeFrame': '6 hours postoperatively', 'description': 'Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization'}, {'measure': 'Incidence of orthostatic hypotension', 'timeFrame': '6 hours postoperatively', 'description': 'Orthostatic hypotension is defined as a fall in systolic pressure \\> 20 mmHg and/or diastolic pressure \\> 10 mmHg during mobilization'}], 'secondaryOutcomes': [{'measure': 'Changes in systolic arterial pressure (SAP) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mmHg, LiDCO-apparatus'}, {'measure': 'Changes in diastolic arterial pressure (DAP) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mmHg, LiDCO-apparatus'}, {'measure': 'Changes in mean arterial pressure (MAP) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mmHg, LiDCO-apparatus'}, {'measure': 'Changes in cardiac output (CO) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mL/min, LiDCO-apparatus'}, {'measure': 'Changes in systemic vascular resistance (SVR) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mmHg⋅min⋅mL-1'}, {'measure': 'Changes in stroke volume (SV) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mL, LiDCO-apparatus'}, {'measure': 'Changes in heart rate variability (HRV) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in ms, LiDCO-apparatus'}, {'measure': 'Changes in peripheral perfusion index (PPI) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in arbitrary units (AU), Massimo apparatus'}, {'measure': 'Changes in cerebral perfusion (ScO2) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in %, NIRS-apparatus'}, {'measure': 'Changes in muscular perfusion (SmO2) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in %, NIRS-apparatus'}, {'measure': 'Changes in haemoglobin (Hgb) concentration', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in millimoles/L'}, {'measure': 'Changes in C-Reactive Protein', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mg/L'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthostatic Hypotension', 'Orthostatic Intolerance', 'Postoperative Complications']}, 'referencesModule': {'references': [{'pmid': '38561817', 'type': 'DERIVED', 'citation': 'Hristovska AM, Andersen LB, Uldall-Hansen B, Kehlet H, Troelsen A, Gromov K, Foss NB. Postoperative orthostatic intolerance following fast-track unicompartmental knee arthroplasty: incidence and hemodynamics-a prospective observational cohort study. J Orthop Surg Res. 2024 Apr 1;19(1):214. doi: 10.1186/s13018-024-04639-6.'}]}, 'descriptionModule': {'briefSummary': 'Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing UKA', 'detailedDescription': "In today's multimodal fast-track perioperative care program (ERAS) early mobilization is an essential cornerstone, and is known to prevent postoperative morbidity and lower length of stay in the hospital. Intact orthostatic blood pressure regulation is necessary to complete mobilization, and postoperative orthostatic hypotension (OH), defined as a drop in systolic arterial pressure (SAP) \\> 20 mmHg or a drop \\>10 mmHg in diastolic arterial pressure (DAP) and orthostatic intolerance (OI), characterized by dizziness, nausea, feeling warm and syncope related to orthostatic challenge, are well-known reasons for delayed early mobilization, prolonged bedrest and delayed ambulation.\n\nFormer studies have been accessing the postoperative incidence in THA-patients (22%-40%), TKA-patients(36%), colorectal patients(53%), abdominal and cardiothoracic surgery patients(40%), radical prostatectomy patients (50%). One study have been accessing the postoperative incidence of OI in mastectomy patients and found an incidence of 4%, and thereby indicating that postoperative OI is not an issue in minor surgery.\n\nThis study is the first, to our acknowledgement, which accesses the postoperative incidence of OI/OH in UKA-patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were screened in the electronic patient system, and were first screened for inclusion criteria, and afterwards exclusion criteria.\n\nPatients were eligible to enroll in the study if they were \\>18 years, spoke and understood Danish, signed an informed consent formula and underwent UKA in spinal anesthesia at Hvidovre Hospital. They were excluded if they had 1) pre-existing orthostatic hypotension or intolerance, 2) Alcohol or substance abuse, 3) everyday treatment with either anxiolytic or antipsychotic medicine 4) Cognitive dysfunction. 5) Or if surgery was converted to general anesthesia or total knee arthroplasty.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years and\n* Patients undergoing UKA in spinal anesthesia at Hvidovre Hospital in a standardized fast-track setting.\n* Patients that speak and understand Danish\n* Written informed consent\n\nExclusion Criteria:\n\n* Pre-existing orthostatic hypotension or intolerance\n* Alcohol or substance abuse\n* everyday treatment with either anxiolytic or antipsychotic medicine\n* Cognitive dysfunction\n* If surgery was converted to general anesthesia or total knee arthroplasty.'}, 'identificationModule': {'nctId': 'NCT04195360', 'briefTitle': 'Postoperative Incidence of Orthostatic Intolerance and Hypotension in Primary Unicompartmental Knee Arthroplasty (UKA)', 'organization': {'class': 'OTHER', 'fullName': 'Copenhagen University Hospital, Hvidovre'}, 'officialTitle': 'Postoperative Incidence of Orthostatic Intolerance and Hypotension in Patients Undergoing Primary Unicompartmental Knee Arthroplasty (UKA)', 'orgStudyIdInfo': {'id': 'H-19063289'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Orthostatic intolerant (OI)', 'description': 'Patients that experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure \\> 20 mmHg and/or diastolic pressure \\> 10 mmHg) during mobilization', 'interventionNames': ['Other: Standardized mobilization procedure']}, {'label': 'Orthostatic tolerant (OT)', 'description': 'Patients that do not experience symptoms of orthostatic intolerance (dizziness, nausea, vomiting, blurry vision or syncope) or orthostatic hypotension (fall in systolic pressure \\> 20 mmHg and/or diastolic pressure \\> 10 mmHg) during mobilization', 'interventionNames': ['Other: Standardized mobilization procedure']}], 'interventions': [{'name': 'Standardized mobilization procedure', 'type': 'OTHER', 'description': '5 minutes bed rest (h1), followed by 3 minutes passive leg raise (PLR), followed by 5 minutes bed rest (h2), followed by 3 minutes sitting on the egde of the bed (sit), followed by 3 minutes standing/walking on the spot (sta), followed by 5 minutes bedrest (h3)', 'armGroupLabels': ['Orthostatic intolerant (OI)', 'Orthostatic tolerant (OT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Hvidovre', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Louise Bundsgaard Andersen, Medical student', 'role': 'CONTACT'}], 'facility': 'Hvidovre Hospital', 'geoPoint': {'lat': 55.64297, 'lon': 12.47708}}], 'centralContacts': [{'name': 'Louise Bundsgaard Andersen, medical student', 'role': 'CONTACT', 'email': 'louise.bundsgaard.andersen.01@regionh.dk', 'phone': '+45 41161599'}, {'name': 'Ana-Marija Hristovska, MD', 'role': 'CONTACT', 'email': 'ana-marija.hristovska.02@regionh.dk', 'phone': '+4538621508'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Copenhagen University Hospital, Hvidovre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kehlet, Henrik, M.D., Ph.D.', 'class': 'INDIV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Undergraduate Student', 'investigatorFullName': 'Louise Bundsgaard Andersen', 'investigatorAffiliation': 'Copenhagen University Hospital, Hvidovre'}}}}