Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty (THA)

Brief Title

Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty (THA)

Official Title

Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty

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.
    


Study Type

Observational


Primary Outcome

Incidence of orthostatic intolerance

Secondary Outcome

 Changes in systolic arterial pressure (SAP) during mobilization

Condition

Orthostatic Intolerance


Study Arms / Comparison Groups

 Orthostatic intolerant (OI)
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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

26

Start Date

March 18, 2019

Completion Date

May 15, 2021

Primary Completion Date

January 1, 2021

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
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, +4538621508, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT03759574

Organization ID

H-18052195


Responsible Party

Principal Investigator

Study Sponsor

Hvidovre University Hospital

Collaborators

 Henrik Kehlet

Study Sponsor

, , 


Verification Date

January 2020