Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:56 PM
Study NCT ID:
NCT04842058
Status:
UNKNOWN
Last Update Posted:
2021-04-12
First Post:
2021-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving ACEIs and ARBs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054971', 'term': 'Orthostatic Intolerance'}, {'id': 'D007024', 'term': 'Hypotension, Orthostatic'}, {'id': 'D054969', 'term': 'Primary Dysautonomias'}], 'ancestors': [{'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007022', 'term': 'Hypotension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-08', 'studyFirstSubmitDate': '2021-04-08', 'studyFirstSubmitQcDate': '2021-04-08', 'lastUpdatePostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain score during mobilisation', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured by verbal rating scale (VRS) from 0 to 10 (0 = no pain, 10 = worse pain imaginable)'}, {'measure': 'Estimated intraoperative bleeding', 'timeFrame': 'During surgery', 'description': 'Measured in mL'}, {'measure': 'Intraoperative fluid balance', 'timeFrame': 'Intraoperative', 'description': 'Measured in mL'}, {'measure': 'Surgery duration', 'timeFrame': 'Intraoperative', 'description': 'Minutes'}, {'measure': 'Intraoperative propofol usage', 'timeFrame': 'Intraoperative', 'description': 'Mg'}, {'measure': 'Usage of cumulated opioids prior to mobilisation', 'timeFrame': 'Postoperatively', 'description': 'mg'}, {'measure': 'Usage of Chlorzoxazone prior to mobilisation', 'timeFrame': 'Postoperatively', 'description': 'mg'}, {'measure': 'Preoperative use of antihypertensives', 'timeFrame': 'Preoperatively', 'description': 'Type, dose and time of administration'}, {'measure': 'Postoperative use of antihypertensives', 'timeFrame': 'Postoperatively', 'description': 'Type, dose and time of administration'}], '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 by non-invasive Lithium Dilution Cardiac Output (LiDCO) measurement'}, {'measure': 'Changes in diastolic arterial pressure (DAP) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mmHg by non-invasive LiDCO'}, {'measure': 'Changes in mean arterial pressure (MAP) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mmHg by non-invasive LiDCO'}, {'measure': 'Changes in systemic vascular resistance (SVR) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in dynes s cm-5 by non-invasive LiDCO'}, {'measure': 'Changes in cardiac output (CO) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in L/min by non-invasive LiDCO'}, {'measure': 'Changes in stroke volume (SV) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mL by non-invasive LiDCO'}, {'measure': 'Changes in heart rate (HR) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in beats min-1 by non-invasive LiDCO'}, {'measure': 'Changes in pulse pressure (PP) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mmHg'}, {'measure': 'Changes in cerebral perfusion (ScO2) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in % by Root Masimo'}, {'measure': 'Changes in muscular perfusion (SmO2) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in % by Root Masimo'}, {'measure': 'Changes in peripheral perfusion index (PPI) during mobilization', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in % by Root Masimo'}, {'measure': 'Changes in total blood volume (TBV)', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mL by Carbon Monoxide - rebreathing technique'}, {'measure': 'Changes in red blood cell volume (RBCV)', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mL by Carbon Monoxide - rebreathing technique'}, {'measure': 'Changes in plasma volume (PV)', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mL by Carbon Monoxide - rebreathing technique'}, {'measure': 'Changes in hematocrit', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in %'}, {'measure': 'Changes in total mass of hemoglobin', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in grams'}, {'measure': 'Changes in hemoglobin concentration', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in gr/L'}, {'measure': 'Changes in C-Reactive Protein', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in mg/L'}, {'measure': 'Changes in heart rate variability (HRV) during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in ms'}, {'measure': 'Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in ms'}, {'measure': 'Changes in Valsalva ratio (VR) during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured as index'}, {'measure': 'Changes in Systolic Sympathetic Index 1 (SSI1) during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured as index'}, {'measure': 'Changes in Systolic Sympathetic Index 2 (SSI2) during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured as index'}, {'measure': 'Changes in Systolic Sympathetic Index 3 (SSI3) during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured as index'}, {'measure': 'Changes in Diastolic Sympathetic Index 1 (DSI1) during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured as index'}, {'measure': 'Changes in Diastolic Sympathetic Index 2 (DSI2) during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured as index'}, {'measure': 'Changes in Diastolic Sympathetic Index 3 (DSI3) during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured as index'}, {'measure': 'Changes in Pressure Recovery Time (PRT) during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in seconds'}, {'measure': 'Changes in Baroreceptor Reflex Sensitivity-adrenergic (BRS-a) during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in seconds'}, {'measure': 'Changes in systolic latency during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in seconds'}, {'measure': 'Changes in diastolic latency during Valsalva manoeuvre', 'timeFrame': 'Preoperatively, 6 and 24 hours postoperatively', 'description': 'Measured in seconds'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orthostatic Hypotension', 'Orthostatic Intolerance', 'Postoperative period', 'Antihypertensives', 'Autonomic dysfunction'], 'conditions': ['Orthostatic Intolerance', 'Orthostatic Hypotension']}, 'referencesModule': {'references': [{'pmid': '22174345', 'type': 'BACKGROUND', 'citation': 'Jans O, Bundgaard-Nielsen M, Solgaard S, Johansson PI, Kehlet H. Orthostatic intolerance during early mobilization after fast-track hip arthroplasty. Br J Anaesth. 2012 Mar;108(3):436-43. doi: 10.1093/bja/aer403. Epub 2011 Dec 15.'}, {'pmid': '27638295', 'type': 'BACKGROUND', 'citation': 'Jans O, Kehlet H. Postoperative orthostatic intolerance: a common perioperative problem with few available solutions. Can J Anaesth. 2017 Jan;64(1):10-15. doi: 10.1007/s12630-016-0734-7. Epub 2016 Sep 14. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Incidence and pathophysiologic hemodynamics of postoperative orthostatic intolerance and orthostatic hypotension in patients receiving antihypertensives', 'detailedDescription': 'Early postoperative mobilization is essential for rapid functional recovery after surgery and it is considered a cornerstone in the so-called fast track multimodal perioperative approach, which includes early ambulation, oral nutrition, multimodal opioid-sparing analgesia and optimized fluid therapy. This strategy has improved patient outcome after surgery and reduced hospital length of stay. Immobilization after surgery is associated with increased risk of complications including venous thromboembolism (deep venous thrombosis, pulmonary embolism), muscle wasting, pneumonia and atelectasis, thereby impending convalescence.\n\nHowever, early postoperative mobilization can be delayed due to failed orthostatic cardiovascular regulation, resulting in postoperative orthostatic hypotension (OH), defined as a decrease in systolic blood pressure \\> 20 mmHg or diastolic blood pressure \\> 10 mmHg or postoperative orthostatic intolerance (OI), characterized by dizziness, nausea, vomiting, visual disturbances or syncope.\n\nPrevious studies investigating the incidence and pathophysiology of postoperative OI and OH included mixed patient populations. Hitherto no studies have been performed looking into the incidence and pathophysiologic hemodynamics of postoperative OI and OH specifically in patients receiving angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II receptor blockers (ARBs), antihypertensive agents with potential effects on cardiovascular compensatory functions.\n\nThe current study aims therefore to estimate the incidence and gain knowledge on pathophysiological hemodynamics of postoperative OI and OH in patients receiving ACEIs and ARBs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving antuhypertensives (ACEIs, ARBs) and undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing primary unilateral total hip arthroplasty (THA) in spinal anaesthesia in standardized fast-track setting\n* Habitual use of angiontensin-Converting Enzyme Inhibitors (ACEIs) and/or angiotensin 2 receptor blockers (ARBs) on any indication\n* Patients \\> 18\n* Patients that understand and speak Danish\n* Patients that have provided written informed consent\n\nExclusion Criteria:\n\n* Alcohol abuse\n* Any type of substance abuse\n* Chronic pain treated by habitual use of opioids\n* Habitual use of anxiolytic, antidepressant and/or antipsychotic drugs\n* History of cerebral apoplexy or transitory cerebral ischemia\n* History of previous orthostatic intolerance or hypotension\n* History of diabetes mellitus\n* History of following diseases of the autonomic nervous system: Parkinson disease, multiple sclerosis, multiple system atrophy, autonomic neuropathies\n* Cognitive dysfunction\n* Dementia\n* American Society of Anesthesiologists (ASA) \\> 3'}, 'identificationModule': {'nctId': 'NCT04842058', 'briefTitle': 'Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving ACEIs and ARBs', 'organization': {'class': 'OTHER', 'fullName': 'Hvidovre University Hospital'}, 'officialTitle': 'Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Blockers (ARBs)', 'orgStudyIdInfo': {'id': 'H-20017723'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Orthostatic tolerant patients (OT)', '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 mobilisation', 'interventionNames': ['Other: Mobilisation procedure']}, {'label': 'Orthostatic intolerant patients (OI)', '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 mobilisation', 'interventionNames': ['Other: Mobilisation procedure']}], 'interventions': [{'name': 'Mobilisation procedure', 'type': 'OTHER', 'description': 'A standardized mobilization procedure was performed preoperatively \\~ 1h before surgery and was repeated 6h and 24h after surgery. The mobilization procedure included patient supine rest (5 minutes), followed by 45° passive leg raise (PLR) (3 minutes), supine rest (5 minutes), sitting on the edge of the bed with feet resting on the floor (3 minutes) followed by standing using a walker while the patient was encouraged verbally to stand on toes and shift body weight from one leg to the other (3 minutes) and finally rest in supine position (5 minutes). The procedure was terminated prematurely in any position if patients experienced unbearable symptoms of OI or upon a decrease of systolic arterial pressure (SAP) \\> 30 mmHg.', 'armGroupLabels': ['Orthostatic intolerant patients (OI)', 'Orthostatic tolerant patients (OT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2960', 'city': 'Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Ana-Marija Hristovska', 'role': 'CONTACT', 'email': 'anamarijahristovska@gmail.com', 'phone': '38621508'}, {'name': 'Nicolai Foss', 'role': 'CONTACT'}], 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hvidovre University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kehlet, Henrik, M.D., Ph.D.', 'class': 'INDIV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ana-Marija Hristovska', 'investigatorAffiliation': 'Hvidovre University Hospital'}}}}