Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty (THA)

Study Overview
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Brief Summary
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Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing unilateral THA

Detailed Description
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Early postoperative mobilization is a cornerstone in the so-called fast track multimodal perioperative approach and is essential in preventing postoperative morbidity and reducing hospital length-of-stay. Intact orthostatic blood pressure regulation is essential for early postoperative mobilization. However, early postoperative mobilization can be delayed due to postoperative orthostatic hypotension (POH) defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg or due to postoperative orthostatic intolerance (POI), characterized by dizziness, nausea, vomiting, blurred vision or syncope during mobilization. Although these conditions are well-known clinical problems that can delay early mobilization, relatively few data are available on pathophysiological mechanisms and possible treatments. Several prospective studies with standardized mobilization procedures have already established that the incidence of POI and POH after THA is 38-42% at 6 hours after surgery. Previous studies on patients undergoing prostatectomy and THA have also demonstrated that attenuated vasopressor response and a concomitant reduction in cardiac output (CO) and cerebral perfusion during postural changes after surgery contributes to POI and POH. Strategies aiming to reduce the incidence of POI and POH by pain management, vasoconstrictive treatment with alpha-1 receptor agonist, optimized fluid management with goal-directed fluid therapy and reduction of surgical stress-response with pre-operative high-dose glucocorticoid did not solve the problem. The precise pathophysiological mechanisms of POI and POH remain to be elucidated and this is therefore the aim of the current prospective observational study.

Official Title
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Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty

Conditions
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Orthostatic Intolerance, Orthostatic Hypotension, Postoperative Complications

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 Written informed consent Patients that speak and understand Danish Patients undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting Exclusion Criteria: Alcohol and drug abuse Cognitive dysfunction History of orthostatic hypotension Use of anxiolytic or antipsychotic drugs Use of opioids Use of following vasodilator antihypertensive drugs: beta-blockers, angiotensin converting enzyme inhibitors (ACEI), angiotensin 2 receptor blockers (ARBs), calcium channel blockers Use of loop diuretics, thiazid diuretics and potassium-sparing diuretics Use of Gabapentin Arrhythmias or heart failure Diabetes mellitus type I Diabetes mellitus type II History of following diseases in the autonomic nervous system: Parkinson disease, multiple sclerosis, autonomic neuropathies History of cerebral apoplexy or transitory cerebral ischemia Dementia American Society of Anesthesiologists (ASA) score ≥ 4

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Orthostatic intolerant (OI)<br>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 | |
| Orthostatic tolerant (OT)<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of orthostatic intolerance | Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization | 6 hours postoperatively | 
| Incidence of orthostatic hypotension | Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization | 6 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in systolic arterial pressure (SAP) during mobilization | Measured in mmHg | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in diastolic arterial pressure (DAP) during mobilization | Measured in mmHg | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in mean arterial pressure (MAP) during mobilization | Measured in mmHg | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in systemic vascular resistance (SVR) during mobilization | Measured in mmHg⋅min⋅mL-1 | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in cardiac output (CO) during mobilization | Measured in mL/min | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in stroke volume (SV) during mobilization | Measured in mL | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in heart rate variability (HRV) during mobilization | Measured in ms | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in baroreflex sensitivity (BRS) during mobilization | Measured in ms/mmHg | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in peripheral perfusion index (PPI) during mobilization | Measured in arbitrary units (AU) | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in cerebral perfusion (ScO2) during mobilization | Measured in % | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in muscular perfusion (SmO2) during mobilization | Measured in % | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in total blood volume (TBV) | Measured in mL | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in erythrocyte volume (ECV) | Measured in mL | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in plasma volume (PV) | Measured in mL | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in hematocrit | Measured in % | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in haemoglobin (Hgb) concentration | Measured in millimoles/L | Preoperatively, 6 and 24 hours postoperatively | 
| Changes in C-Reactive Protein | Measured in mg/L | Preoperatively, 6 and 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Orthostatic Intolerance, Orthostatic Hypotension