ShockNCT05554783
Analysis of Passive Leg Raise Test on Blood Pressure in Critically Ill Patients.
An observational study of Shock and Hypovolemia, run by Medical University of Gdansk at 1 site in Poland.
Trial summary
Positioning intensive care patients in Trendelenburg position to identify fluid responsiveness assessed by PiCCO device. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Shock, Hypovolemia, Hemodynamic Instability
- What is being tested?
- Trendelenburg position
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 6 Jun 2021to 31 Dec 2023
- 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 85 years
- All sexes
- Adult, Older adult
Study population: Patients admitted to Intensive Care Unit of University Clinical Centre in Gdańsk
Who may be able to join
- hemodynamic instability
- mechanical ventilation
Who cannot join
- increased intracranial pressure
- increased intraabdominal pressure
- lower limbs sequential compression system
- agitation
- patients exposed to pain stimulus before the test
- aortic aneurysm
- left to right cardiac shunt
- severe valvular insufficiency
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Gdańsk - Department of Anesthesiology and Intensive Care
Gdansk, Pomeranian Voivodeship
Jan Stefaniak, M.D., +48583493270, klanest@gumed.edu.pl
About this study
Positioning intensive care patients in Trendelenburg position to identify fluid responsiveness assessed by PiCCO device.
Read the detailed description
It is a prospective observational study. Patients admitted to Intensive Care Unit of University Clinical Centre of Gdańsk, receiving advanced hemodynamic monitoring with PiCCO method will be enrolled. After blood pressure measurement, PiCCO will be calibrated with transpulmonary thermodilution with 10 - 20 ml of cold saline. Readings will be noted. The patient will be positioned in Trendelenburg position with it's head 15 degrees down. The increase of blood pressure after positioning in relation to the values obtained before the trial will be correlated to the parameters that asses patent's volaemia. After 5 minutes patient will be back to supine position and hemodynamic parameters will be recorded for another 5 minute.
- Conditions
- Shock, Hypovolemia, Hemodynamic Instability
- Being tested
- Trendelenburg position
- Medical subject headings
- Shock, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trendelenburg positionDiagnostic test
Positioning the patient with head 15 degrees down
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of SVV with increase in blood pressure
Stroke volume variation (SVV) is a validated parameter that assess fluid responsiveness. In patients in whom SVV value is higher, theoretically Trendelenburg position will increase blood pressure in greater degree, than in patients in whom SVV is lower. We want to identify whether such correlation exist.
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 posted26 Sep 2022
- Study start6 Jun 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Stefaniak, M.D., Principal investigator, Medical University of Gdańsk, Department of Anesthesiology and Intensive TherapyRadosław Owczuk, M.D., Ph.D., Study director, Medical University of Gdańsk, Department of Anesthesiology and Intensive Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554783
- Sponsor's protocol ID
- PLRonBP
- Status last verified
- Sep 2022
- First submitted
- 21 Apr 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Passive Leg Raise Test on Blood Pressure in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT05554783
- Acronym / sponsor ID
- PLRonBP
- Conditions
- Shock, Hypovolemia, Hemodynamic Instability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- 6 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Sep 2022 (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.
Positioning intensive care patients in Trendelenburg position to identify fluid responsiveness assessed by PiCCO device.
Detailed description
It is a prospective observational study. Patients admitted to Intensive Care Unit of University Clinical Centre of Gdańsk, receiving advanced hemodynamic monitoring with PiCCO method will be enrolled. After blood pressure measurement, PiCCO will be calibrated with transpulmonary thermodilution with 10 - 20 ml of cold saline. Readings will be noted. The patient will be positioned in Trendelenburg position with it's head 15 degrees down. The increase of blood pressure after positioning in relation to the values obtained before the trial will be correlated to the parameters that asses patent's volaemia. After 5 minutes patient will be back to supine position and hemodynamic parameters will be recorded for another 5 minute.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to Intensive Care Unit of University Clinical Centre in Gdańsk
Key inclusion criteria (2 listed)
- hemodynamic instability
- mechanical ventilation
Key exclusion criteria (8 listed)
- increased intracranial pressure
- increased intraabdominal pressure
- lower limbs sequential compression system
- agitation
- patients exposed to pain stimulus before the test
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 |
|---|---|---|
| Trendelenburg positionPositioning the patient with head 15 degrees down | Diagnostic test | – |
Primary outcome
Correlation of SVV with increase in blood pressure
Time frame: 10 minutes
Stroke volume variation (SVV) is a validated parameter that assess fluid responsiveness. In patients in whom SVV value is higher, theoretically Trendelenburg position will increase blood pressure in greater degree, than in patients in whom SVV is lower. We want to identify whether such correlation exist.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
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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.
Jan Stefaniak, M.D. principal investigator
Medical University of Gdańsk, Department of Anesthesiology and Intensive Therapy
Radosław Owczuk, M.D., Ph.D. study director
Medical University of Gdańsk, Department of Anesthesiology and Intensive Therapy
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 Shock and Hypovolemia, run by Medical University of Gdansk at 1 site in Poland.
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 8 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 26 Sep 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 Poland. 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 Jan Stefaniak, M.D. (+48583493270, klanest@gumed.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of SVV with increase in blood pressure (time frame: 10 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 26 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.