Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty (THA)

NCT ID: NCT03759574

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-18

Study Completion Date

2021-05-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Orthostatic Intolerance Orthostatic Hypotension Postoperative Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Orthostatic intolerant (OI)

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

No interventions assigned to this group

Orthostatic tolerant (OT)

Patients that do not 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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kehlet, Henrik, M.D., Ph.D.

INDIV

Sponsor Role collaborator

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ana-Marija Hristovska

Prinicial Investigator, Medical Doctor, PhD-student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hvidovre Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Ana-Marija Hristovska, MD

Role: CONTACT

+4538621508

Nicolai Foss, MD

Role: CONTACT

Facility Contacts

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Ana-Marija Hristovska, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 22174345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29573263 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26492477 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23756453 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27638295 (View on PubMed)

Other Identifiers

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H-18052195

Identifier Type: -

Identifier Source: org_study_id

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