Orthostatic IntoleranceNCT03759574
Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty (THA)
An observational study of Orthostatic Intolerance and Orthostatic Hypotension, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing unilateral THA Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Orthostatic Intolerance, Orthostatic Hypotension, Postoperative Complications
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Mar 2019to 15 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Nicolai Foss, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre Hospital
Copenhagen
Ana-Marija Hristovska, MD
About this study
Official title: Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty
Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing unilateral THA
Read the 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.
- Keywords
- Orthostatic Intolerance, Orthostatic Hypotension
- Medical subject headings
- Orthostatic Intolerance, Hypotension, Orthostatic, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of orthostatic intolerance
Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Measured: 6 hours postoperatively
Incidence of orthostatic hypotension
Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization
Measured: 6 hours postoperatively
Secondary outcomes (17)
Changes in systolic arterial pressure (SAP) during mobilization
Measured in mmHg
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in diastolic arterial pressure (DAP) during mobilization
Measured in mmHg
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in mean arterial pressure (MAP) during mobilization
Measured in mmHg
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in systemic vascular resistance (SVR) during mobilization
Measured in mmHg⋅min⋅mL-1
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in cardiac output (CO) during mobilization
Measured in mL/min
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in stroke volume (SV) during mobilization
Measured in mL
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in heart rate variability (HRV) during mobilization
Measured in ms
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in baroreflex sensitivity (BRS) during mobilization
Measured in ms/mmHg
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in peripheral perfusion index (PPI) during mobilization
Measured in arbitrary units (AU)
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in cerebral perfusion (ScO2) during mobilization
Measured in %
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in muscular perfusion (SmO2) during mobilization
Measured in %
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in total blood volume (TBV)
Measured in mL
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in erythrocyte volume (ECV)
Measured in mL
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in plasma volume (PV)
Measured in mL
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in hematocrit
Measured in %
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in haemoglobin (Hgb) concentration
Measured in millimoles/L
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in C-Reactive Protein
Measured in mg/L
Measured: Preoperatively, 6 and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start18 Mar 2019
- Primary completion1 Jan 2021 (estimated)
- Study completion15 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Orthostatic IntoleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D.
- Responsible party
- Principal investigator, Ana-Marija Hristovska, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03759574
- Sponsor's protocol ID
- H-18052195
- Status last verified
- Jan 2020
- First submitted
- 28 Nov 2018
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22174345Lindberg-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.
PubMed 29573263Jans 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.
PubMed 26492477Bundgaard-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.
PubMed 23756453Jans 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.
PubMed 27638295
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathophysiologic Hemodynamics After Primary Unilateral Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03759574
- Acronym / sponsor ID
- H-18052195
- Keywords
- Orthostatic Intolerance, Orthostatic Hypotension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D.
- Study start
- 18 Mar 2019 (actual)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 15 May 2021 (estimated)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary unilateral total hip arthroplasty in spinal anesthesia in standardized fast-track setting
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- Alcohol and drug abuse
- Cognitive dysfunction
- History of orthostatic hypotension
- Use of anxiolytic or antipsychotic drugs
- Use of opioids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of orthostatic intolerance
Time frame: 6 hours postoperatively
Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization
Incidence of orthostatic hypotension
Time frame: 6 hours postoperatively
Orthostatic hypotension is defined as a fall in systolic pressure > 20 mmHg and/or diastolic pressure > 10 mmHg during mobilization
17 secondary outcomes
Changes in systolic arterial pressure (SAP) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in diastolic arterial pressure (DAP) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in mean arterial pressure (MAP) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in systemic vascular resistance (SVR) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in cardiac output (CO) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in stroke volume (SV) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in heart rate variability (HRV) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in baroreflex sensitivity (BRS) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in peripheral perfusion index (PPI) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in cerebral perfusion (ScO2) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in muscular perfusion (SmO2) during mobilization
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in total blood volume (TBV)
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in erythrocyte volume (ECV)
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in plasma volume (PV)
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in hematocrit
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in haemoglobin (Hgb) concentration
Time frame: Preoperatively, 6 and 24 hours postoperatively
Changes in C-Reactive Protein
Time frame: Preoperatively, 6 and 24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Background: PubMed 22174345Jans 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.
- Background: PubMed 29573263Lindberg-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.
- Background: PubMed 26492477Jans 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.
- Background: PubMed 23756453Bundgaard-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.
- Background: PubMed 27638295Jans 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicolai Foss, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthostatic Intolerance and Orthostatic Hypotension, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana-Marija Hristovska, MD (+4538621508, ana-marija.hristovska.02@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of orthostatic intolerance (time frame: 6 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03759574, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.