Orthostatic IntoleranceNCT03743116
Postoperative Orthostatic Intolerance and Hypotension in Unilateral TKA
An observational study of Orthostatic Intolerance and Orthostatic Hypotension, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Orthostatic Intolerance, Orthostatic Hypotension, Postoperative Complications
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Nov 2018to 1 Mar 2020
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and standardized fast-track setting
Who may be able to join
- Age ≥ 18
- Written informed consent
- Patients that speak and understand Danish
- Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and standardized fast-track setting
Who cannot join
- Alcohol or drug abuse
- Cognitive dysfunction
- Known orthostatic hypotension
- Use of anxiolytic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty
Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty
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.
Previous prospective studies of major surgery have reported that OI and OH are common problem during early postoperative mobilization, with a prevalence of 42-50%. Retrospective studies with a less-defined mobilization protocols have reported am OI prevalence in the range of 12-60 % across surgical procedures.
The aim of our study is to determine the incidence of OI during early postoperative mobilization in fast track unilateral total knee arthroplasty.
- Keywords
- Orthostatic Intolerance, Orthostatic Hypotension, Knee arthroplasty
- 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 (6)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start13 Nov 2018
- Primary completion1 Jul 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50 participants (actual)
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
- Investigators
- Ana-Marija Hristovska, MD, Principal investigator, Department of Anesthesiology, Hvidovre Hospital, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743116
- Sponsor's protocol ID
- H-18049929
- Status last verified
- Aug 2022
- First submitted
- 8 Nov 2018
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03743116
- Acronym / sponsor ID
- H-18049929
- Keywords
- Orthostatic Intolerance, Orthostatic Hypotension, Knee arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D.
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 15 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 of Postoperative Orthostatic Intolerance and Postoperative Orthostatic Hypotension in Patients Undergoing Unilateral Total Knee Arthroplasty
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.
Previous prospective studies of major surgery have reported that OI and OH are common problem during early postoperative mobilization, with a prevalence of 42-50%. Retrospective studies with a less-defined mobilization protocols have reported am OI prevalence in the range of 12-60 % across surgical procedures.
The aim of our study is to determine the incidence of OI during early postoperative mobilization in fast track unilateral total knee arthroplasty.
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 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and standardized fast-track setting
Key inclusion criteria (4 listed)
- Age ≥ 18
- Written informed consent
- Patients that speak and understand Danish
- Patients undergoing primary unilateral total knee arthroplasty in spinal anesthesia and standardized fast-track setting
Key exclusion criteria (4 listed)
- Alcohol or drug abuse
- Cognitive dysfunction
- Known orthostatic hypotension
- Use of anxiolytic drugs
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
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2022.
- 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.
Ana-Marija Hristovska, MD principal investigator
Department of Anesthesiology, Hvidovre Hospital, Copenhagen
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 4 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: finished, as of the sponsor's last update on 30 Aug 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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?
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 30 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.