- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04842058
Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving ACEIs and ARBs
Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty in Patients Receiving Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Blockers (ARBs)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Copenhagen, Denmark, 2960
- Recruiting
- Hvidovre University Hospital
-
Contact:
- Ana-Marija Hristovska
- Phone Number: 38621508
- Email: anamarijahristovska@gmail.com
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Contact:
- Nicolai Foss
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Orthostatic tolerant patients (OT)
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
|
A standardized mobilization procedure was performed preoperatively ~ 1h before surgery and was repeated 6h and 24h after surgery.
The mobilization procedure included patient supine rest (5 minutes), followed by 45° passive leg raise (PLR) (3 minutes), supine rest (5 minutes), sitting on the edge of the bed with feet resting on the floor (3 minutes) followed by standing using a walker while the patient was encouraged verbally to stand on toes and shift body weight from one leg to the other (3 minutes) and finally rest in supine position (5 minutes).
The procedure was terminated prematurely in any position if patients experienced unbearable symptoms of OI or upon a decrease of systolic arterial pressure (SAP) > 30 mmHg.
|
Orthostatic intolerant patients (OI)
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
|
A standardized mobilization procedure was performed preoperatively ~ 1h before surgery and was repeated 6h and 24h after surgery.
The mobilization procedure included patient supine rest (5 minutes), followed by 45° passive leg raise (PLR) (3 minutes), supine rest (5 minutes), sitting on the edge of the bed with feet resting on the floor (3 minutes) followed by standing using a walker while the patient was encouraged verbally to stand on toes and shift body weight from one leg to the other (3 minutes) and finally rest in supine position (5 minutes).
The procedure was terminated prematurely in any position if patients experienced unbearable symptoms of OI or upon a decrease of systolic arterial pressure (SAP) > 30 mmHg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of orthostatic intolerance
Time Frame: 6 hours postoperatively
|
Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
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6 hours postoperatively
|
Incidence of orthostatic hypotension
Time Frame: 6 hours postoperatively
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Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization
|
6 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in systolic arterial pressure (SAP) during mobilization
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in mmHg by non-invasive Lithium Dilution Cardiac Output (LiDCO) measurement
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in diastolic arterial pressure (DAP) during mobilization
Time Frame: Preoperatively, 6 and 24 hours postoperatively
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Measured in mmHg by non-invasive LiDCO
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in mean arterial pressure (MAP) during mobilization
Time Frame: Preoperatively, 6 and 24 hours postoperatively
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Measured in mmHg by non-invasive LiDCO
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in systemic vascular resistance (SVR) during mobilization
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in dynes s cm-5 by non-invasive LiDCO
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in cardiac output (CO) during mobilization
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in L/min by non-invasive LiDCO
|
Preoperatively, 6 and 24 hours postoperatively
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Changes in stroke volume (SV) during mobilization
Time Frame: Preoperatively, 6 and 24 hours postoperatively
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Measured in mL by non-invasive LiDCO
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in heart rate (HR) during mobilization
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in beats min-1 by non-invasive LiDCO
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in pulse pressure (PP) during mobilization
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in mmHg
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in cerebral perfusion (ScO2) during mobilization
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in % by Root Masimo
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in muscular perfusion (SmO2) during mobilization
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in % by Root Masimo
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in peripheral perfusion index (PPI) during mobilization
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in % by Root Masimo
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in total blood volume (TBV)
Time Frame: Preoperatively, 6 and 24 hours postoperatively
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Measured in mL by Carbon Monoxide - rebreathing technique
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Preoperatively, 6 and 24 hours postoperatively
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Changes in red blood cell volume (RBCV)
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in mL by Carbon Monoxide - rebreathing technique
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in plasma volume (PV)
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in mL by Carbon Monoxide - rebreathing technique
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in hematocrit
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in %
|
Preoperatively, 6 and 24 hours postoperatively
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Changes in total mass of hemoglobin
Time Frame: Preoperatively, 6 and 24 hours postoperatively
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Measured in grams
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in hemoglobin concentration
Time Frame: Preoperatively, 6 and 24 hours postoperatively
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Measured in gr/L
|
Preoperatively, 6 and 24 hours postoperatively
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Changes in C-Reactive Protein
Time Frame: Preoperatively, 6 and 24 hours postoperatively
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Measured in mg/L
|
Preoperatively, 6 and 24 hours postoperatively
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Changes in heart rate variability (HRV) during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
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Measured in ms
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Preoperatively, 6 and 24 hours postoperatively
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Changes in baroreflex sensitivity - vagal (BRSv) during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in ms
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in Valsalva ratio (VR) during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured as index
|
Preoperatively, 6 and 24 hours postoperatively
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Changes in Systolic Sympathetic Index 1 (SSI1) during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
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Measured as index
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in Systolic Sympathetic Index 2 (SSI2) during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured as index
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in Systolic Sympathetic Index 3 (SSI3) during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured as index
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in Diastolic Sympathetic Index 1 (DSI1) during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured as index
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in Diastolic Sympathetic Index 2 (DSI2) during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured as index
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in Diastolic Sympathetic Index 3 (DSI3) during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured as index
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in Pressure Recovery Time (PRT) during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in seconds
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in Baroreceptor Reflex Sensitivity-adrenergic (BRS-a) during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in seconds
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in systolic latency during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in seconds
|
Preoperatively, 6 and 24 hours postoperatively
|
Changes in diastolic latency during Valsalva manoeuvre
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured in seconds
|
Preoperatively, 6 and 24 hours postoperatively
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surgery duration
Time Frame: Intraoperative
|
Minutes
|
Intraoperative
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Pain score during mobilisation
Time Frame: Preoperatively, 6 and 24 hours postoperatively
|
Measured by verbal rating scale (VRS) from 0 to 10 (0 = no pain, 10 = worse pain imaginable)
|
Preoperatively, 6 and 24 hours postoperatively
|
Estimated intraoperative bleeding
Time Frame: During surgery
|
Measured in mL
|
During surgery
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Intraoperative fluid balance
Time Frame: Intraoperative
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Measured in mL
|
Intraoperative
|
Intraoperative propofol usage
Time Frame: Intraoperative
|
Mg
|
Intraoperative
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Usage of cumulated opioids prior to mobilisation
Time Frame: Postoperatively
|
mg
|
Postoperatively
|
Usage of Chlorzoxazone prior to mobilisation
Time Frame: Postoperatively
|
mg
|
Postoperatively
|
Preoperative use of antihypertensives
Time Frame: Preoperatively
|
Type, dose and time of administration
|
Preoperatively
|
Postoperative use of antihypertensives
Time Frame: Postoperatively
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Type, dose and time of administration
|
Postoperatively
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-20017723
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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