Stroke VolumePLRNCT05882240
Performance of PLR as Predicting Preload Responsiveness
An observational study of Stroke Volume, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
We aimed to establish current practice of correct application and interpretation of the PLR in critical care patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke Volume
- What is being tested?
- choice of initial position
- How many people
- 292 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2021to 28 Feb 2022
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: All Critical care physicians
Who may be able to join
- All Critical care physicians of different medical disciplines
Who cannot join
- not completely responses
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
About this study
Official title: Evaluation of the Correct Performance and Knowledge About the Passive Leg Raise Test to Detect a Volume Reagibility in Critical Care Patients.
We aimed to establish current practice of correct application and interpretation of the PLR in critical care patients.
Read the detailed description
The points of concern for PLR include the following: the indication and contraindication of PLR; the choice of initial position: starting from a semi-recumbent position or supine position for PLR; how to interpret and apply the changes of CO, blood pressure, and central venous pressure (CVP) to identify fluid response during PLR; and how to identify spontaneous variation and sympathetic stimulation during PLR.
- Conditions
- Stroke Volume
- Being tested
- choice of initial position
- Keywords
- passive leg raise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
choice of initial positionOther
Also called Measurement of effect size
current practice of correct application and interpretation of the PLR in critical care patients
What is being measured
The primary outcome is the main question the study is designed to answer.
We aimed to establish current practice of correct application and interpretation of the PLR in critical care patients
Application and Interpretation of correct effect size
Measured: through study completion, an average of Measurement in 5 Minutes
Secondary outcomes (2)
Profession
Profession of the respondents
Measured: < 10 Minutes
Measurement of cardiac output
correct response of stroke volume
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 posted31 May 2023
- Study start1 Dec 2021
- Primary completion31 Jan 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke VolumeStudies 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
- Cross-sectional
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc Kriege, Principal investigator, University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882240
- Sponsor's protocol ID
- JohannesGUVT
- Acronym
- PLR
- Status last verified
- May 2023
- First submitted
- 11 May 2023
- Last updated
- 31 May 2023
- 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 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Correct Performance and Knowledge About the Passive Leg Raise Test to Detect a Volume Reagibility in Critical Care Patients.
- ClinicalTrials.gov ID
- NCT05882240
- Acronym / sponsor ID
- PLR / JohannesGUVT
- Conditions
- Stroke Volume
- Keywords
- passive leg raise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 31 May 2023 (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.
We aimed to establish current practice of correct application and interpretation of the PLR in critical care patients.
Detailed description
The points of concern for PLR include the following: the indication and contraindication of PLR; the choice of initial position: starting from a semi-recumbent position or supine position for PLR; how to interpret and apply the changes of CO, blood pressure, and central venous pressure (CVP) to identify fluid response during PLR; and how to identify spontaneous variation and sympathetic stimulation during PLR.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All Critical care physicians
Key inclusion criteria (1 listed)
- All Critical care physicians of different medical disciplines
Key exclusion criteria (1 listed)
- not completely responses
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 |
|---|---|---|
| choice of initial positionAlso: Measurement of effect sizecurrent practice of correct application and interpretation of the PLR in critical care patients | Other | – |
Primary outcome
We aimed to establish current practice of correct application and interpretation of the PLR in critical care patients
Time frame: through study completion, an average of Measurement in 5 Minutes
Application and Interpretation of correct effect size
2 secondary outcomes
Profession
Time frame: < 10 Minutes
Measurement of cardiac output
Time frame: < 10 Minutes
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 31 May 2023.
- 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.
Marc Kriege principal investigator
University Medical Centre
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 Stroke Volume, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 31 May 2023. 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 Germany. 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?
We aimed to establish current practice of correct application and interpretation of the PLR in critical care patients (time frame: through study completion, an average of Measurement in 5 Minutes). 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 31 May 2023.