Passive Leg RaisingNCT04260841
Passive Leg Raising and Fluid Responsiveness
An observational study of Passive Leg Raising, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
In the Intensive Care the Passive Leg Raising (PLR) test is a validated instrument to predict fluid responsiveness. In this study the investigators will try to prove the similarity of PLR test with a pillow and the PLR test with the patients bed in 45 degrees. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Passive Leg Raising
- What is being tested?
- bed in 45 degrees for passive leg raising test
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2017to 1 Nov 2019
- 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
- Adult, Older adult
Study population: Patients admitted to the ICU with clinical signs of fluid need
Who may be able to join
- admission on Intensive Care
- clinical signs as; mean arterial pressure < 60, lactate > 2.0 mmol/L
Who cannot join
- age < 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Passive Leg Raising 3.0 and Fluid Responsiveness
In the Intensive Care the Passive Leg Raising (PLR) test is a validated instrument to predict fluid responsiveness. In this study the investigators will try to prove the similarity of PLR test with a pillow and the PLR test with the patients bed in 45 degrees.
Read the detailed description
PLR test with pillow PLR test with bed to avoid a difference in results by the order of the measurements, the order of PLR testing is random.
- Conditions
- Passive Leg Raising
- Being tested
- bed in 45 degrees for passive leg raising test
- Keywords
- fluid responsiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bed in 45 degrees for passive leg raising testDevice
Also called use of "pillow" for passive leg raising test
fluid responsiveness is tested by the passive leg raising test
What is being measured
The primary outcome is the main question the study is designed to answer.
fluid responsiveness expressed in volume
are both PLR tests similar / comparable on fluid responsiveness
Measured: from ICU admission until ICU discharge; test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
blood pressure expressed in mmHg
are both PLR tests similar / comparable on fluid responsiveness
Measured: test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
cardiac output
are both PLR tests similar / comparable on fluid responsiveness
Measured: test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Jun 2017
- Primary completion1 Nov 2019
- Study completion1 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Passive Leg RaisingStudies 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
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matty Koopmans, Frisius Medisch Centrum
- Investigators
- Matty Koopmans, MSc, Principal investigator, MCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260841
- Sponsor's protocol ID
- nWMO 217
- Status last verified
- Feb 2020
- First submitted
- 9 Jun 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Passive Leg Raising 3.0 and Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT04260841
- Acronym / sponsor ID
- nWMO 217
- Conditions
- Passive Leg Raising
- Keywords
- fluid responsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 1 Nov 2019 (actual)
- First posted
- 7 Feb 2020 (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.
In the Intensive Care the Passive Leg Raising (PLR) test is a validated instrument to predict fluid responsiveness. In this study the investigators will try to prove the similarity of PLR test with a pillow and the PLR test with the patients bed in 45 degrees.
Detailed description
PLR test with pillow PLR test with bed to avoid a difference in results by the order of the measurements, the order of PLR testing is random.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the ICU with clinical signs of fluid need
Key inclusion criteria (2 listed)
- admission on Intensive Care
- clinical signs as; mean arterial pressure < 60, lactate > 2.0 mmol/L
Key exclusion criteria (1 listed)
- age < 18
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 |
|---|---|---|
| bed in 45 degrees for passive leg raising testAlso: use of "pillow" for passive leg raising testfluid responsiveness is tested by the passive leg raising test | Device | – |
Primary outcome
fluid responsiveness expressed in volume
Time frame: from ICU admission until ICU discharge; test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
are both PLR tests similar / comparable on fluid responsiveness
blood pressure expressed in mmHg
Time frame: test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
are both PLR tests similar / comparable on fluid responsiveness
cardiac output
Time frame: test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days
are both PLR tests similar / comparable on fluid responsiveness
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 7 Feb 2020.
- Individual participant dataSharing planned: No
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Not yet recruitingObservational study
Role of End-Tidal CO2 During Passive Leg Raising to Predict Fluid Responsiveness in ICU
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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.
Matty Koopmans, MSc principal investigator
MCL
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 Passive Leg Raising, run by Frisius Medisch Centrum at 1 site in Netherlands.
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 2 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 7 Feb 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 Netherlands. 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?
fluid responsiveness expressed in volume (time frame: from ICU admission until ICU discharge; test performed on the moment of clinical signs of fluid need through study completion, an average of 5 days). The study lists 3 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 7 Feb 2020.