Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving ACEIs and ARBs

Brief Title

Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving ACEIs and ARBs

Official Title

Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Blockers (ARBs)

Brief Summary

      Incidence and pathophysiologic hemodynamics of postoperative orthostatic intolerance and
      orthostatic hypotension in patients receiving antihypertensives
    

Detailed Description

      Early postoperative mobilization is essential for rapid functional recovery after surgery and
      it is considered a cornerstone in the so-called fast track multimodal perioperative approach,
      which includes early ambulation, oral nutrition, multimodal opioid-sparing analgesia and
      optimized fluid therapy. This strategy has improved patient outcome after surgery and reduced
      hospital length of stay. Immobilization after surgery is associated with increased risk of
      complications including venous thromboembolism (deep venous thrombosis, pulmonary embolism),
      muscle wasting, pneumonia and atelectasis, thereby impending convalescence.

      However, early postoperative mobilization can be delayed due to failed orthostatic
      cardiovascular regulation, resulting in postoperative orthostatic hypotension (OH), defined
      as a decrease in systolic blood pressure > 20 mmHg or diastolic blood pressure > 10 mmHg or
      postoperative orthostatic intolerance (OI), characterized by dizziness, nausea, vomiting,
      visual disturbances or syncope.

      Previous studies investigating the incidence and pathophysiology of postoperative OI and OH
      included mixed patient populations. Hitherto no studies have been performed looking into the
      incidence and pathophysiologic hemodynamics of postoperative OI and OH specifically in
      patients receiving angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II
      receptor blockers (ARBs), antihypertensive agents with potential effects on cardiovascular
      compensatory functions.

      The current study aims therefore to estimate the incidence and gain knowledge on
      pathophysiological hemodynamics of postoperative OI and OH in patients receiving ACEIs and
      ARBs.
    


Study Type

Observational


Primary Outcome

Incidence of orthostatic intolerance

Secondary Outcome

 Changes in systolic arterial pressure (SAP) during mobilization

Condition

Orthostatic Intolerance

Intervention

Mobilisation procedure

Study Arms / Comparison Groups

 Orthostatic tolerant patients (OT)
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


Recruitment Status

Other

Estimated Enrollment

24

Start Date

December 1, 2020

Completion Date

December 1, 2023

Primary Completion Date

December 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Patients undergoing primary unilateral total hip arthroplasty (THA) in spinal
             anaesthesia in standardized fast-track setting

          -  Habitual use of angiontensin-Converting Enzyme Inhibitors (ACEIs) and/or angiotensin 2
             receptor blockers (ARBs) on any indication

          -  Patients > 18

          -  Patients that understand and speak Danish

          -  Patients that have provided written informed consent

        Exclusion Criteria:

          -  Alcohol abuse

          -  Any type of substance abuse

          -  Chronic pain treated by habitual use of opioids

          -  Habitual use of anxiolytic, antidepressant and/or antipsychotic drugs

          -  History of cerebral apoplexy or transitory cerebral ischemia

          -  History of previous orthostatic intolerance or hypotension

          -  History of diabetes mellitus

          -  History of following diseases of the autonomic nervous system: Parkinson disease,
             multiple sclerosis, multiple system atrophy, autonomic neuropathies

          -  Cognitive dysfunction

          -  Dementia

          -  American Society of Anesthesiologists (ASA) > 3
      

Gender

All

Ages

18 Years - N/A


Contacts

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Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT04842058

Organization ID

H-20017723


Responsible Party

Principal Investigator

Study Sponsor

Hvidovre University Hospital

Collaborators

 Henrik Kehlet

Study Sponsor

, , 


Verification Date

April 2021