Circulatory FailurePLRNCT06285331
the Impact of Manual or Mechanical Ways to Perform PLR on the Accuracy of Evaluation of Fluid Responsiveness
A study testing Automatic Bed and Manual in people with Circulatory Failure, run by Southeast University, China at 1 site in China.
Trial summary
Our goal was to study the impact of different ways to perform passive leg raising (PLR) on the accuracy of evaluation of fluid responsiveness. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Circulatory Failure
- What is being tested?
- Automatic Bed and Manual
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2023to 31 Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) patients who have signs of tissue hypo-perfusion (increasing lactate levels, in need of vasopressor agents to maintain blood pressure, oliguria, and weak consciousness), and need to evaluate their fluid responsiveness; (2) patients who have received Pulse indicator Continuous Cardiac Output (PiCCO) monitoring ; (3) patients who are transferred into the intensive care department.
Who cannot join
- (1) Age < 18 years old, or > 75 years old (2) pregnancy or lactation; (3) refusal to sign the informed consent form for enrollment; (4) patients who are clearly unable to perform passive leg raising (PLR) (intra-abdominal pressure ≥16cmH2O, high risk of lower limb venous thrombosis, intracranial hypertension, and recent undergone abdominal or pelvic surgery); (5) patients with the contraindications of fluid resuscitation therapy ( pulmonary edema, intracranial hypertension and so on); (6) patients clinical doctors assessed as unsuitable for PLR.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Jingyuan Xu, M.D.
About this study
Official title: the Impact of Manual or Mechanical Ways to Perform Passive Leg Raising on the Accuracy of Evaluation of Fluid Responsiveness
Our goal was to study the impact of different ways to perform passive leg raising (PLR) on the accuracy of evaluation of fluid responsiveness.
Read the detailed description
Patients who have shock of all kinds of reasons usually need to be transferred to the Intensive Care Unit(ICU) for monitoring and treatment due to unstable vital signs and high fatal risks. The cardiac function of these patients requires special attention. Fluid responsiveness is a comprehensive reflection of preload and cardiac function, which provides guidance on how to conduct fluid replacement therapy. When patients have fluid responsiveness, it means that after fluid resuscitation therapy, the patients' cardiac output will increase and tissue perfusion will improve, bringing benefits to patients themselves. Therefore, it is of vital significance to evaluate the presence of fluid responsiveness in patients before fluid therapy in clinical practice. Passive leg raising(PLR) is a commonly used method in clinical practice to evaluate patients' fluid responsiveness. But its accuracy is affected by the way the leg lifting is performed.
This project is aimed to explore the impact of different ways to perform passive leg raising on the accuracy of evaluation of fluid responsiveness.
- Conditions
- Circulatory Failure
- Being tested
- Automatic Bed, Manual
- Keywords
- Fluid Responsiveness, Passive Leg Raising
- Medical subject headings
- Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automatic BedDevice
The automatic bed is controlled by a screen and allows clinicians to perform passive leg raising on patients without touching them physically.
ManualDevice
The clinicians will perform passive leg raising on patients by touching their legs physically.
| Study group | Role | What they receive |
|---|---|---|
| Automatic Bed | Active comparator | PLR will be performed by adjusting the automatic bed the patients stay on. Receives: Device: Automatic Bed |
| Manual | Placebo comparator | PLR will be performed by the investigators by their hands. Receives: Device: Manual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of fluid responsiveness evaluation
It is the results of accuracy of evaluation of patients' fluid responsiveness by performing PLR by different ways. The accuracy is evaluated by comparing the results of PLR and fluid challenge test. The cardio output of patients is obtained by Pulse indicator Continuous Cardiac Output (PiCCO). The results of PLR are considered accurate if the results of the patient's volume responsiveness measured by different methods of PLR are consistent with the results obtained by the fluid challenge test.
Measured: Immediately after procedure
Secondary outcomes (1)
Mortality
The mortality of patients within 90 days after PLR was performed.
Measured: 90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start6 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory FailureStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingyuan,Xu, Southeast University, China
- Investigators
- Jingyuan Xu, M.D., Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06285331
- Sponsor's protocol ID
- 2023ZDSYLL483-P01
- Acronym
- PLR
- Status last verified
- May 2024
- First submitted
- 9 Jan 2024
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Impact of Manual or Mechanical Ways to Perform Passive Leg Raising on the Accuracy of Evaluation of Fluid Responsiveness
- ClinicalTrials.gov ID
- NCT06285331
- Acronym / sponsor ID
- PLR / 2023ZDSYLL483-P01
- Conditions
- Circulatory Failure
- Keywords
- Fluid Responsiveness, Passive Leg Raising
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Feb 2024 (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.
Our goal was to study the impact of different ways to perform passive leg raising (PLR) on the accuracy of evaluation of fluid responsiveness.
Detailed description
Patients who have shock of all kinds of reasons usually need to be transferred to the Intensive Care Unit(ICU) for monitoring and treatment due to unstable vital signs and high fatal risks. The cardiac function of these patients requires special attention. Fluid responsiveness is a comprehensive reflection of preload and cardiac function, which provides guidance on how to conduct fluid replacement therapy. When patients have fluid responsiveness, it means that after fluid resuscitation therapy, the patients' cardiac output will increase and tissue perfusion will improve, bringing benefits to patients themselves. Therefore, it is of vital significance to evaluate the presence of fluid responsiveness in patients before fluid therapy in clinical practice. Passive leg raising(PLR) is a commonly used method in clinical practice to evaluate patients' fluid responsiveness. But its accuracy is affected by the way the leg lifting is performed.
This project is aimed to explore the impact of different ways to perform passive leg raising on the accuracy of evaluation of fluid responsiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automatic Bed | Active comparator | Device: Automatic BedPLR will be performed by adjusting the automatic bed the patients stay on. |
| Manual | Placebo comparator | Device: ManualPLR will be performed by the investigators by their hands. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) patients who have signs of tissue hypo-perfusion (increasing lactate levels, in need of vasopressor agents to maintain blood pressure, oliguria, and weak consciousness), and need to evaluate their fluid responsiveness; (2) patients who have received Pulse indicator Continuous Cardiac Output (PiCCO) monitoring ; (3) patients who are transferred into the intensive care department.
Key exclusion criteria (1 listed)
- (1) Age < 18 years old, or > 75 years old (2) pregnancy or lactation; (3) refusal to sign the informed consent form for enrollment; (4) patients who are clearly unable to perform passive leg raising (PLR) (intra-abdominal pressure ≥16cmH2O, high risk of lower limb venous thrombosis, intracranial hypertension, and recent undergone abdominal or pelvic surgery); (5) patients with the contraindications of fluid resuscitation therapy ( pulmonary edema, intracranial hypertension and so on); (6) patients clinical doctors assessed as unsuitable for PLR.
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 |
|---|---|---|
| Automatic BedThe automatic bed is controlled by a screen and allows clinicians to perform passive leg raising on patients without touching them physically. | Device | Automatic Bed |
| ManualThe clinicians will perform passive leg raising on patients by touching their legs physically. | Device | Manual |
Primary outcome
Accuracy of fluid responsiveness evaluation
Time frame: Immediately after procedure
It is the results of accuracy of evaluation of patients' fluid responsiveness by performing PLR by different ways. The accuracy is evaluated by comparing the results of PLR and fluid challenge test. The cardio output of patients is obtained by Pulse indicator Continuous Cardiac Output (PiCCO). The results of PLR are considered accurate if the results of the patient's volume responsiveness measured by different methods of PLR are consistent with the results obtained by the fluid challenge test.
1 secondary outcome
Mortality
Time frame: 90days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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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.
Jingyuan Xu, M.D. principal investigator
Zhongda 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 Automatic Bed and Manual in people with Circulatory Failure, run by Southeast University, China at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 21 May 2024. 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 China. 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. Some participants in this study may receive a placebo. 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 Jingyuan Xu, M.D. (8602583262550, xujingyuanmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of fluid responsiveness evaluation (time frame: Immediately after procedure). 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 21 May 2024.