Cardiovascular InsufficiencyPLR-ANSNCT03454802
Passive Leg Raising - an Important Diagnostic Manoeuvre
A study testing Passive Leg Raising in people with Cardiovascular Insufficiency, run by Region MidtJylland Denmark at 1 site in Denmark.
Trial summary
The aim is to describe the physiological background for PLR and the interpretation of a PLR manoeuvre. The protocol entails the measurement of stroke volume (SV) at baseline (semirecumbent patient position), during PLR and after returning to semirecumbent position. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Insufficiency
- What is being tested?
- Passive Leg Raising
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2018to 1 Oct 2020
- Phase
- Interventional
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consenting after written and oral information
Who cannot join
- Contraindications to PLR: intracranial or abdominal hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Passive Leg Raising - an Important Diagnostic Manoeuvre and Its Dependency on the Activity of the Autonomous Nervous System in Critically Ill Patients and Healthy Subjects
The aim is to describe the physiological background for PLR and the interpretation of a PLR manoeuvre.
The protocol entails the measurement of stroke volume (SV) at baseline (semirecumbent patient position), during PLR and after returning to semirecumbent position. Simultaneously blood pressure (BP), pulse rate (PR), pulse oximetric saturation (SpO2) and ECG are recorded. The procedure is performed in ten normal subjects, ten patients recruited in the cardiology outpatient department and ten critically ill patients under analgosedation in the ICU.
Analysis includes changes in measured variables and heart rate variability in the frequency domain during the three phases of the experiment.
Read the detailed description
See above
- Conditions
- Cardiovascular Insufficiency
- Being tested
- Passive Leg Raising
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Leg RaisingDiagnostic test
See above
| Study group | Role | What they receive |
|---|---|---|
| Normal subjects | Active comparator | Normal subjects 'Passive Leg Raising' Receives: Diagnostic Test: Passive Leg Raising |
| ICU patients | Active comparator | ICU patients 'Passive Leg Raising' Receives: Diagnostic Test: Passive Leg Raising |
| Cardiac Outpatients | Active comparator | Cardiac Outpatients 'Passive Leg Raising' Receives: Diagnostic Test: Passive Leg Raising |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in cardiovascular variables I
stroke volume, SV (mL)
Measured: 10 minutes
Changes in cardiovascular variables II
pulse rate, PR (min^-1)
Measured: 10 minutes
Changes in cardiovascular variables III
blood pressure, BP (mmHg)
Measured: 10 minutes
Changes in cardiovascular variables IV
pulse oximetric saturation, SpO2 (%)
Measured: 10 minutes
Changes in HRV frequency domain variables V
Heart rate variability, HRV, variables in frequency domain (low frequency, LF, 0.04-0.15 Hz, high frequency, HF, 0.15-0.4 Hz)
Measured: 10 minutes
Changes in HRV frequency domain variables VI
HRV absolute power (ms^2, natural logarithm transformed values of absolute powers of very low frequency, VLF, LF, and HF bands)
Measured: 10 minutes
Changes in HRV frequency domain variables VII
HRV relative power (absolute power/total power)
Measured: 10 minutes
Changes in HRV frequency domain variables VIII
HRV normalized power (%, normalized units, n.u.)
Measured: 10 minutes
Changes in HRV frequency domain variables IX
HRV total power given by VLF + HF + LF (ms2) and LF/HF ratio.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start1 Sep 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
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 Cardiovascular InsufficiencyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region MidtJylland Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Principal investigator, Soren Sondergaard, Region MidtJylland Denmark
- Investigators
- Peter Toft, MD, Study chair, Head of Centre of Planned Surgery, Silkeborg Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03454802
- Sponsor's protocol ID
- 619909
- Acronym
- PLR-ANS
- Status last verified
- Sep 2021
- First submitted
- 10 Feb 2018
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
PubMed 16540963
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Leg Raising - an Important Diagnostic Manoeuvre and Its Dependency on the Activity of the Autonomous Nervous System in Critically Ill Patients and Healthy Subjects
- ClinicalTrials.gov ID
- NCT03454802
- Acronym / sponsor ID
- PLR-ANS / 619909
- Conditions
- Cardiovascular Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Region MidtJylland DenmarkUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 6 Mar 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.
The aim is to describe the physiological background for PLR and the interpretation of a PLR manoeuvre.
The protocol entails the measurement of stroke volume (SV) at baseline (semirecumbent patient position), during PLR and after returning to semirecumbent position. Simultaneously blood pressure (BP), pulse rate (PR), pulse oximetric saturation (SpO2) and ECG are recorded. The procedure is performed in ten normal subjects, ten patients recruited in the cardiology outpatient department and ten critically ill patients under analgosedation in the ICU.
Analysis includes changes in measured variables and heart rate variability in the frequency domain during the three phases of the experiment.
Detailed description
See above
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal subjects | Active comparator | Diagnostic Test: Passive Leg RaisingNormal subjects 'Passive Leg Raising' |
| ICU patients | Active comparator | Diagnostic Test: Passive Leg RaisingICU patients 'Passive Leg Raising' |
| Cardiac Outpatients | Active comparator | Diagnostic Test: Passive Leg RaisingCardiac Outpatients 'Passive Leg Raising' |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting after written and oral information
Key exclusion criteria (1 listed)
- Contraindications to PLR: intracranial or abdominal hypertension
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 |
|---|---|---|
| Passive Leg RaisingSee above | Diagnostic test | Cardiac Outpatients, ICU patients, Normal subjects |
Primary outcome
Changes in cardiovascular variables I
Time frame: 10 minutes
stroke volume, SV (mL)
Changes in cardiovascular variables II
Time frame: 10 minutes
pulse rate, PR (min^-1)
Changes in cardiovascular variables III
Time frame: 10 minutes
blood pressure, BP (mmHg)
Changes in cardiovascular variables IV
Time frame: 10 minutes
pulse oximetric saturation, SpO2 (%)
Changes in HRV frequency domain variables V
Time frame: 10 minutes
Heart rate variability, HRV, variables in frequency domain (low frequency, LF, 0.04-0.15 Hz, high frequency, HF, 0.15-0.4 Hz)
Changes in HRV frequency domain variables VI
Time frame: 10 minutes
HRV absolute power (ms^2, natural logarithm transformed values of absolute powers of very low frequency, VLF, LF, and HF bands)
Changes in HRV frequency domain variables VII
Time frame: 10 minutes
HRV relative power (absolute power/total power)
Changes in HRV frequency domain variables VIII
Time frame: 10 minutes
HRV normalized power (%, normalized units, n.u.)
Changes in HRV frequency domain variables IX
Time frame: 10 minutes
HRV total power given by VLF + HF + LF (ms2) and LF/HF ratio.
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 24 Sep 2021.
- Results publication: PubMed 16540963Monnet X, Rienzo M, Osman D, Anguel N, Richard C, Pinsky MR, Teboul JL. Passive leg raising predicts fluid responsiveness in the critically ill. Crit Care Med. 2006 May;34(5):1402-7. doi: 10.1097/01.CCM.0000215453.11735.06.
- 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.
Peter Toft, MD study chair
Head of Centre of Planned Surgery, Silkeborg Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive Leg Raising in people with Cardiovascular Insufficiency, run by Region MidtJylland Denmark 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 1 inclusion and 1 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 24 Sep 2021. 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?
Changes in cardiovascular variables I (time frame: 10 minutes). The study lists 9 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 NCT03454802, 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 24 Sep 2021.