Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty (THA)

Postoperative Complications Clinical Trial

Official title:

Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03759574
• Other study ID #: H-18052195
• Status: Recruiting
• Start date: March 18, 2019
• Est. completion date: May 15, 2021

Study information

• Verified date: January 2020
• Source: Hvidovre University Hospital
• Contact: Ana-Marija Hristovska, MD
• Phone: +4538621508
• Email: ana-marija.hristovska.02[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: May 15, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension
• Orthostatic Intolerance
• Postoperative Complications

Locations

Country	Name	City	State
Denmark	Hvidovre Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Hvidovre University Hospital	Henrik Kehlet

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

Bundgaard-Nielsen M, Jans Ø, Müller 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. — View Citation

Jans Ø, 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. — View Citation

Jans Ø, 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. — View Citation

Jans Ø, Mehlsen J, Kjærsgaard-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. — View Citation

Lindberg-Larsen V, Petersen PB, Jans Ø, 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain score	Measured by verbal rating scale (VRS) from 0 to 10 (0 = no pain, 10 = worse pain imaginable)	Preoperatively, 6 and 24 hours postoperatively
Other	Estimated bleeding	Measured in mL	Intraoperatively, 6 and 24 hours postoperatively
Other	Opioid use	Measured in mg	6 and 24 hours postoperatively
Other	Cumulative fluid administration and losses	Measured in mg	Intraoperatively, 6 and 24 hours postoperatively
Primary	Incidence of orthostatic intolerance	Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization	6 hours postoperatively
Primary	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	Changes in systolic arterial pressure (SAP) during mobilization	Measured in mmHg	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in diastolic arterial pressure (DAP) during mobilization	Measured in mmHg	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in mean arterial pressure (MAP) during mobilization	Measured in mmHg	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in systemic vascular resistance (SVR) during mobilization	Measured in mmHg·min·mL-1	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in cardiac output (CO) during mobilization	Measured in mL/min	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in stroke volume (SV) during mobilization	Measured in mL	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in heart rate variability (HRV) during mobilization	Measured in ms	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in baroreflex sensitivity (BRS) during mobilization	Measured in ms/mmHg	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in peripheral perfusion index (PPI) during mobilization	Measured in arbitrary units (AU)	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in cerebral perfusion (ScO2) during mobilization	Measured in %	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in muscular perfusion (SmO2) during mobilization	Measured in %	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in total blood volume (TBV)	Measured in mL	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in erythrocyte volume (ECV)	Measured in mL	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in plasma volume (PV)	Measured in mL	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in hematocrit	Measured in %	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in haemoglobin (Hgb) concentration	Measured in millimoles/L	Preoperatively, 6 and 24 hours postoperatively
Secondary	Changes in C-Reactive Protein	Measured in mg/L	Preoperatively, 6 and 24 hours postoperatively