Cardiac SurgeryNCT04604886
The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients
A study testing Passive Leg Raising and Dobutamine stress test in people with Cardiac Surgery and Cardiac Output, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
1. To evaluate the consistency of cardiac output measured by pulmonary artery catheter and LiDCO in cardiac surgical patients 2. To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery, Cardiac Output
- What is being tested?
- Passive Leg Raising and Dobutamine stress test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2020to 30 Jun 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cardiac surgery
- hemodynamic monitoring (PAC, LiDCO)
- mechanical ventilation
Who cannot join
- cardiac arrhythmia
- moderate to severe aortic, mitral and tricuspid regurgitation
- IABP
- ECMO
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
180 Fenglin Road
Shanghai, 200032
Guo-wei Tu, Doctor, 86-021-64041990, tu.guowei@zs-hospital.sh.cn
About this study
- To evaluate the consistency of cardiac output measured by pulmonary artery catheter and LiDCO in cardiac surgical patients
- To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes
Read the detailed description
Close monitoring of cardiac output (CO), especially in patients before and after intervention(such as volume expansion, diuresis, vasoconstriction, vasodilation therapy), could help to adjust the treatment strategy in cardiac surgical patients. Pulmonary artery catherization (PAC) has been used for hemodynamic monitoring for more than four decades. In spite of its invasiveness, it remains the clinical reference method for the assessment of CO at the bedside. Nowadays, many less invasive alternatives, such as LiDCO Rapid Pulse Contour Analysis System (LiDCO Ltd., Cambridge, United Kingdom), are already available on market. However, consistency between different hemodynamic monitoring results still raise concern. And whether hemodynamic monitoring could accurately detect the changes of these parameters before and after intervention is an important issue in clinical practice. In this study, the investigators are going to collect CO and changes of CO from PAC and LiDCO before and after intervention (passive leg raising and dobutamine stress test) in cardiac surgical patients. Our resulst could provide important reference for cardiac surgical patients how to choose appropriate hemodynamic monitoring tools and how to interpret the results of hemodynamic monitoring.
- Conditions
- Cardiac Surgery, Cardiac Output
- Being tested
- Passive Leg Raising, Dobutamine stress test
- Keywords
- Hemodynamic Monitoring, Pulmonary artery catherization, LiDCO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive Leg RaisingDiagnostic test
Passive leg raising is induced by rasing the legs of patients to 45° from horizontal position.
Dobutamine stress testDiagnostic test
Dobutamine was infused intravenously at the initial dose of 2.5 ug/kg/min. hemodynamic data were recorded from PAC and LiDCO after 5-10 minutes of continuous infusion.
| Study group | Role | What they receive |
|---|---|---|
| Passive Leg Raising | Experimental | Passive leg raising (PLR) test is used to predict fluid responsiveness, which is performed by raising the legs of the patient to 45°. Cardiac output will be collected from both PAC and LiDCO before and after PLR. Receives: Diagnostic Test: Passive Leg Raising |
| Dobutamine stress test | Experimental | Dobutamine is a selective beta 1 receptor agonist. It [<10 ug/(kg.min)] can effectively increase myocardial contractility. Receives: Diagnostic Test: Dobutamine stress test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Cardiac Output measurement
Cardiac Output measured at baseline position (horizontal position)
Measured: within1 minute at baseline position
Cardiac Output measurement after PLR
Cardiac Output measured after PLR
Measured: 1 minute after PLR
Cardiac Output measurement after Dobutamine stress test
Cardiac Output measured after dobutamine stress test
Measured: 5 minutes after dobutamine stress test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start30 Sep 2020
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhe Luo, Doctor, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604886
- Sponsor's protocol ID
- COMPACT-LiDCO
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT04604886
- Acronym / sponsor ID
- COMPACT-LiDCO
- Conditions
- Cardiac Surgery, Cardiac Output
- Keywords
- Hemodynamic Monitoring, Pulmonary artery catherization, LiDCO
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 27 Oct 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.
- To evaluate the consistency of cardiac output measured by pulmonary artery catheter and LiDCO in cardiac surgical patients
- To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes
Detailed description
Close monitoring of cardiac output (CO), especially in patients before and after intervention(such as volume expansion, diuresis, vasoconstriction, vasodilation therapy), could help to adjust the treatment strategy in cardiac surgical patients. Pulmonary artery catherization (PAC) has been used for hemodynamic monitoring for more than four decades. In spite of its invasiveness, it remains the clinical reference method for the assessment of CO at the bedside. Nowadays, many less invasive alternatives, such as LiDCO Rapid Pulse Contour Analysis System (LiDCO Ltd., Cambridge, United Kingdom), are already available on market. However, consistency between different hemodynamic monitoring results still raise concern. And whether hemodynamic monitoring could accurately detect the changes of these parameters before and after intervention is an important issue in clinical practice. In this study, the investigators are going to collect CO and changes of CO from PAC and LiDCO before and after intervention (passive leg raising and dobutamine stress test) in cardiac surgical patients. Our resulst could provide important reference for cardiac surgical patients how to choose appropriate hemodynamic monitoring tools and how to interpret the results of hemodynamic monitoring.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive Leg Raising | Experimental | Diagnostic Test: Passive Leg RaisingPassive leg raising (PLR) test is used to predict fluid responsiveness, which is performed by raising the legs of the patient to 45°. Cardiac output will be collected from both PAC and LiDCO before and after PLR. |
| Dobutamine stress test | Experimental | Diagnostic Test: Dobutamine stress testDobutamine is a selective beta 1 receptor agonist. It [<10 ug/(kg.min)] can effectively increase myocardial contractility. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- cardiac surgery
- hemodynamic monitoring (PAC, LiDCO)
- mechanical ventilation
Key exclusion criteria (4 listed)
- cardiac arrhythmia
- moderate to severe aortic, mitral and tricuspid regurgitation
- IABP
- ECMO
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 RaisingPassive leg raising is induced by rasing the legs of patients to 45° from horizontal position. | Diagnostic test | Passive Leg Raising |
| Dobutamine stress testDobutamine was infused intravenously at the initial dose of 2.5 ug/kg/min. hemodynamic data were recorded from PAC and LiDCO after 5-10 minutes of continuous infusion. | Diagnostic test | Dobutamine stress test |
Primary outcome
Baseline Cardiac Output measurement
Time frame: within1 minute at baseline position
Cardiac Output measured at baseline position (horizontal position)
Cardiac Output measurement after PLR
Time frame: 1 minute after PLR
Cardiac Output measured after PLR
Cardiac Output measurement after Dobutamine stress test
Time frame: 5 minutes after dobutamine stress test
Cardiac Output measured after dobutamine stress test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
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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.
Zhe Luo, Doctor study chair
Fudan University
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 and Dobutamine stress test in people with Cardiac Surgery and Cardiac Output, run by Shanghai Zhongshan Hospital 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 3 inclusion and 4 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 29 Oct 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 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. 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 Guo-wei Tu, Doctor (86-021-64041990, tu.guowei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Cardiac Output measurement (time frame: within1 minute at baseline position). 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 29 Oct 2020.