Orthostatic HypotensionNCT04195360
Postoperative Incidence of Orthostatic Intolerance and Hypotension in Primary Unicompartmental Knee Arthroplasty (UKA)
An observational study of Orthostatic Hypotension and Orthostatic Intolerance, run by Copenhagen University Hospital, Hvidovre at 1 site in Denmark.
Trial summary
Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing UKA Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthostatic Hypotension, Orthostatic Intolerance, Postoperative Complications
- What is being tested?
- Standardized mobilization procedure
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 2 Dec 2019to 1 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were screened in the electronic patient system, and were first screened for inclusion criteria, and afterwards exclusion criteria. Patients were eligible to enroll in the study if they were >18 years, spoke and understood Danish, signed an informed consent formula and underwent UKA in spinal anesthesia at Hvidovre Hospital. They were excluded if they had 1) pre-existing orthostatic hypotension or intolerance, 2) Alcohol or substance abuse, 3) everyday treatment with either anxiolytic or antipsychotic medicine 4) Cognitive dysfunction. 5) Or if surgery was converted to general anesthesia or total knee arthroplasty.
Who may be able to join
- Age >18 years and
- Patients undergoing UKA in spinal anesthesia at Hvidovre Hospital in a standardized fast-track setting.
- Patients that speak and understand Danish
- Written informed consent
Who cannot join
- Pre-existing orthostatic hypotension or intolerance
- Alcohol or substance abuse
- everyday treatment with either anxiolytic or antipsychotic medicine
- Cognitive dysfunction
- If surgery was converted to general anesthesia or total knee arthroplasty.
Trial locations and contacts
1 site in 1 country.
Louise Bundsgaard Andersen, medical student contact
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre Hospital
Hvidovre, 2650
Louise Bundsgaard Andersen, Medical student
About this study
Official title: Postoperative Incidence of Orthostatic Intolerance and Hypotension in Patients Undergoing Primary Unicompartmental Knee Arthroplasty (UKA)
Incidence and pathophysiologic hemodynamics of orthostatic intolerance and orthostatic hypotension in patients undergoing UKA
Read the detailed description
In today's multimodal fast-track perioperative care program (ERAS) early mobilization is an essential cornerstone, and is known to prevent postoperative morbidity and lower length of stay in the hospital. Intact orthostatic blood pressure regulation is necessary to complete mobilization, and postoperative orthostatic hypotension (OH), defined as a drop in systolic arterial pressure (SAP) > 20 mmHg or a drop >10 mmHg in diastolic arterial pressure (DAP) and orthostatic intolerance (OI), characterized by dizziness, nausea, feeling warm and syncope related to orthostatic challenge, are well-known reasons for delayed early mobilization, prolonged bedrest and delayed ambulation.
Former studies have been accessing the postoperative incidence in THA-patients (22%-40%), TKA-patients(36%), colorectal patients(53%), abdominal and cardiothoracic surgery patients(40%), radical prostatectomy patients (50%). One study have been accessing the postoperative incidence of OI in mastectomy patients and found an incidence of 4%, and thereby indicating that postoperative OI is not an issue in minor surgery.
This study is the first, to our acknowledgement, which accesses the postoperative incidence of OI/OH in UKA-patients.
- Being tested
- Standardized mobilization procedure
- Medical subject headings
- Hypotension, Orthostatic, Orthostatic Intolerance, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized mobilization procedureOther
5 minutes bed rest (h1), followed by 3 minutes passive leg raise (PLR), followed by 5 minutes bed rest (h2), followed by 3 minutes sitting on the egde of the bed (sit), followed by 3 minutes standing/walking on the spot (sta), followed by 5 minutes bedrest (h3)
| 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 mobilization Receives: Other: Standardized mobilization procedure | |
| 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 mobilization Receives: Other: Standardized mobilization procedure |
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 (12)
Changes in systolic arterial pressure (SAP) during mobilization
Measured in mmHg, LiDCO-apparatus
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in diastolic arterial pressure (DAP) during mobilization
Measured in mmHg, LiDCO-apparatus
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in mean arterial pressure (MAP) during mobilization
Measured in mmHg, LiDCO-apparatus
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in cardiac output (CO) during mobilization
Measured in mL/min, LiDCO-apparatus
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 stroke volume (SV) during mobilization
Measured in mL, LiDCO-apparatus
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in heart rate variability (HRV) during mobilization
Measured in ms, LiDCO-apparatus
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in peripheral perfusion index (PPI) during mobilization
Measured in arbitrary units (AU), Massimo apparatus
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in cerebral perfusion (ScO2) during mobilization
Measured in %, NIRS-apparatus
Measured: Preoperatively, 6 and 24 hours postoperatively
Changes in muscular perfusion (SmO2) during mobilization
Measured in %, NIRS-apparatus
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 posted11 Dec 2019
- Study start2 Dec 2019
- Primary completion31 Mar 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthostatic HypotensionStudies 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D.
- Responsible party
- Principal investigator, Louise Bundsgaard Andersen, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195360
- Sponsor's protocol ID
- H-19063289
- Status last verified
- Dec 2019
- First submitted
- 2 Dec 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hristovska AM, Andersen LB, Uldall-Hansen B, Kehlet H, Troelsen A, Gromov K, Foss NB. Postoperative orthostatic intolerance following fast-track unicompartmental knee arthroplasty: incidence and hemodynamics-a prospective observational cohort study. J Orthop Surg Res. 2024 Apr 1;19(1):214. doi: 10.1186/s13018-024-04639-6.
PubMed 38561817
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Incidence of Orthostatic Intolerance and Hypotension in Patients Undergoing Primary Unicompartmental Knee Arthroplasty (UKA)
- ClinicalTrials.gov ID
- NCT04195360
- Acronym / sponsor ID
- H-19063289
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- Kehlet, Henrik, M.D., Ph.D.
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 11 Dec 2019 (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 UKA
Detailed description
In today's multimodal fast-track perioperative care program (ERAS) early mobilization is an essential cornerstone, and is known to prevent postoperative morbidity and lower length of stay in the hospital. Intact orthostatic blood pressure regulation is necessary to complete mobilization, and postoperative orthostatic hypotension (OH), defined as a drop in systolic arterial pressure (SAP) > 20 mmHg or a drop >10 mmHg in diastolic arterial pressure (DAP) and orthostatic intolerance (OI), characterized by dizziness, nausea, feeling warm and syncope related to orthostatic challenge, are well-known reasons for delayed early mobilization, prolonged bedrest and delayed ambulation.
Former studies have been accessing the postoperative incidence in THA-patients (22%-40%), TKA-patients(36%), colorectal patients(53%), abdominal and cardiothoracic surgery patients(40%), radical prostatectomy patients (50%). One study have been accessing the postoperative incidence of OI in mastectomy patients and found an incidence of 4%, and thereby indicating that postoperative OI is not an issue in minor surgery.
This study is the first, to our acknowledgement, which accesses the postoperative incidence of OI/OH in UKA-patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthostatic intolerant (OI) | – | Other: Standardized mobilization procedurePatients 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 mobilization |
| Orthostatic tolerant (OT) | – | Other: Standardized mobilization procedurePatients 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 mobilization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were screened in the electronic patient system, and were first screened for inclusion criteria, and afterwards exclusion criteria. Patients were eligible to enroll in the study if they were >18 years, spoke and understood Danish, signed an informed consent formula and underwent UKA in spinal anesthesia at Hvidovre Hospital. They were excluded if they had 1) pre-existing orthostatic hypotension or intolerance, 2) Alcohol or substance abuse, 3) everyday treatment with either anxiolytic or antipsychotic medicine 4) Cognitive dysfunction. 5) Or if surgery was converted to general anesthesia or total knee arthroplasty.
Key inclusion criteria (4 listed)
- Age >18 years and
- Patients undergoing UKA in spinal anesthesia at Hvidovre Hospital in a standardized fast-track setting.
- Patients that speak and understand Danish
- Written informed consent
Key exclusion criteria (5 listed)
- Pre-existing orthostatic hypotension or intolerance
- Alcohol or substance abuse
- everyday treatment with either anxiolytic or antipsychotic medicine
- Cognitive dysfunction
- If surgery was converted to general anesthesia or total knee arthroplasty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized mobilization procedure5 minutes bed rest (h1), followed by 3 minutes passive leg raise (PLR), followed by 5 minutes bed rest (h2), followed by 3 minutes sitting on the egde of the bed (sit), followed by 3 minutes standing/walking on the spot (sta), followed by 5 minutes bedrest (h3) | Other | Orthostatic intolerant (OI), Orthostatic tolerant (OT) |
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
12 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 cardiac output (CO) 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 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 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 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 13 Dec 2019.
- Derived from this study: PubMed 38561817Hristovska AM, Andersen LB, Uldall-Hansen B, Kehlet H, Troelsen A, Gromov K, Foss NB. Postoperative orthostatic intolerance following fast-track unicompartmental knee arthroplasty: incidence and hemodynamics-a prospective observational cohort study. J Orthop Surg Res. 2024 Apr 1;19(1):214. doi: 10.1186/s13018-024-04639-6.
- 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.
Louise Bundsgaard Andersen, medical student 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 Hypotension and Orthostatic Intolerance, run by Copenhagen University Hospital, Hvidovre 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 5 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 13 Dec 2019. 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 Louise Bundsgaard Andersen, medical student (+45 41161599, louise.bundsgaard.andersen.01@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 NCT04195360, which also lists 1 linked publication.
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 13 Dec 2019.