Skip to content

Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty (THA)

Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03759574
Enrollment
26
Registered
2018-11-30
Start date
2019-03-18
Completion date
2021-05-15
Last updated
2020-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthostatic Hypotension, Orthostatic Intolerance, Postoperative Complications

Keywords

Orthostatic Intolerance, Orthostatic Hypotension

Brief summary

Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing unilateral THA

Detailed description

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.

Interventions

None listed

Sponsors

Kehlet, Henrik, M.D., Ph.D.
CollaboratorINDIV
Hvidovre University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of orthostatic intolerance6 hours postoperativelySymptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Incidence of orthostatic hypotension6 hours postoperativelyOrthostatic hypotension is defined as a fall in systolic pressure \> 20 mmHg and/or diastolic pressure \> 10 mmHg during mobilization

Secondary

MeasureTime frameDescription
Changes in baroreflex sensitivity (BRS) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in ms/mmHg
Changes in plasma volume (PV)Preoperatively, 6 and 24 hours postoperativelyMeasured in mL
Changes in hematocritPreoperatively, 6 and 24 hours postoperativelyMeasured in %
Changes in haemoglobin (Hgb) concentrationPreoperatively, 6 and 24 hours postoperativelyMeasured in millimoles/L
Changes in C-Reactive ProteinPreoperatively, 6 and 24 hours postoperativelyMeasured in mg/L
Changes in systolic arterial pressure (SAP) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mmHg
Changes in diastolic arterial pressure (DAP) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mmHg
Changes in mean arterial pressure (MAP) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mmHg
Changes in systemic vascular resistance (SVR) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mmHg⋅min⋅mL-1
Changes in cardiac output (CO) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mL/min
Changes in stroke volume (SV) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in mL
Changes in heart rate variability (HRV) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in ms
Changes in peripheral perfusion index (PPI) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in arbitrary units (AU)
Changes in cerebral perfusion (ScO2) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in %
Changes in muscular perfusion (SmO2) during mobilizationPreoperatively, 6 and 24 hours postoperativelyMeasured in %
Changes in total blood volume (TBV)Preoperatively, 6 and 24 hours postoperativelyMeasured in mL
Changes in erythrocyte volume (ECV)Preoperatively, 6 and 24 hours postoperativelyMeasured in mL

Other

MeasureTime frameDescription
Cumulative fluid administration and lossesIntraoperatively, 6 and 24 hours postoperativelyMeasured in mg
Opioid use6 and 24 hours postoperativelyMeasured in mg
Pain scorePreoperatively, 6 and 24 hours postoperativelyMeasured by verbal rating scale (VRS) from 0 to 10 (0 = no pain, 10 = worse pain imaginable)
Estimated bleedingIntraoperatively, 6 and 24 hours postoperativelyMeasured in mL

Countries

Denmark

Contacts

Primary ContactAna-Marija Hristovska, MD
ana-marija.hristovska.02@regionh.dk+4538621508
Backup ContactNicolai Foss, MD
nicolai.bang.foss@regionh.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026