Clinical trial NCT03759574: Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty (THA)
Official title: Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Orthostatic Intolerance
Orthostatic Hypotension
Postoperative Complications
Keywords: Orthostatic Intolerance
Orthostatic Hypotension
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Kehlet, Henrik, M.D., Ph.D.
First posted: 2018-11-30
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of orthostatic intolerance
timeFrame: 6 hours postoperatively
measure: Incidence of orthostatic hypotension
timeFrame: 6 hours postoperatively
Secondary outcomes:
measure: Changes in systolic arterial pressure (SAP) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in diastolic arterial pressure (DAP) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in mean arterial pressure (MAP) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in systemic vascular resistance (SVR) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in cardiac output (CO) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in stroke volume (SV) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in heart rate variability (HRV) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in baroreflex sensitivity (BRS) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in peripheral perfusion index (PPI) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in cerebral perfusion (ScO2) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in muscular perfusion (SmO2) during mobilization
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in total blood volume (TBV)
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in erythrocyte volume (ECV)
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in plasma volume (PV)
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in hematocrit
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in haemoglobin (Hgb) concentration
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Changes in C-Reactive Protein
timeFrame: Preoperatively, 6 and 24 hours postoperatively
Other outcomes:
measure: Pain score
timeFrame: Preoperatively, 6 and 24 hours postoperatively
measure: Estimated bleeding
timeFrame: Intraoperatively, 6 and 24 hours postoperatively
measure: Opioid use
timeFrame: 6 and 24 hours postoperatively
measure: Cumulative fluid administration and losses
timeFrame: Intraoperatively, 6 and 24 hours postoperatively
Locations:
city: Copenhagen
country: Denmark
facility: Hvidovre Hospital
Study officials:
References:
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.
citation: Lindberg-Larsen V, Petersen PB, Jans O, Beck T, Kehlet H. Effect of pre-operative methylprednisolone on orthostatic hypotension during early mobilization after total hip arthroplasty. Acta Anaesthesiol Scand. 2018 Aug;62(7):882-892. doi: 10.1111/aas.13108. Epub 2018 Mar 24.
citation: Jans O, Mehlsen J, Kjaersgaard-Andersen P, Husted H, Solgaard S, Josiassen J, Lunn TH, Kehlet H. Oral Midodrine Hydrochloride for Prevention of Orthostatic Hypotension during Early Mobilization after Hip Arthroplasty: A Randomized, Double-blind, Placebo-controlled Trial. Anesthesiology. 2015 Dec;123(6):1292-300. doi: 10.1097/ALN.0000000000000890.
citation: Bundgaard-Nielsen M, Jans O, Muller RG, Korshin A, Ruhnau B, Bie P, Secher NH, Kehlet H. Does goal-directed fluid therapy affect postoperative orthostatic intolerance?: A randomized trial. Anesthesiology. 2013 Oct;119(4):813-23. doi: 10.1097/ALN.0b013e31829ce4ea.
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.