Cardiac SurgeryNCT05944146
Consistency of Carotid Doppler Blood Flow and Thermodilution Technique
A study testing passive leg raising and Dobutamine in people with Cardiac Surgery, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Currently, the gold standard method to estimate CO is the thermodilution technique, pulmonary artery catheter (PAC) and PiCCO system included, however, the invasiveness and complexity of the thermodilution technique have limited their usefulness in many clinical scenarios. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- passive leg raising and Dobutamine
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- adult cardiac surgery patients
- with thermodilution technique monitoring
- mechanical ventilation
Who cannot join
- life threatening arrhythmia
- severe valve regurgitation
- left ventricular ejection fraction less than 30%
- patients with mechanical circulatory support
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital Fudan University
Shanghai, Shanghai Municipality, 200040
Guang-wei Hao, 02164041990, haoguangwei@zs-hospital.sh.cn
About this study
Official title: The Consistency of Tracking Changes of Cardiac Output by Carotid Doppler Blood Flow and Thermodilution Technique in Cardiac Surgery Patients
Currently, the gold standard method to estimate CO is the thermodilution technique, pulmonary artery catheter (PAC) and PiCCO system included, however, the invasiveness and complexity of the thermodilution technique have limited their usefulness in many clinical scenarios. By measuring the carotid blood flow, continuous carotid doppler technique has been reported to noninvasively estimate cardiac output (CO) and other parameters related to cardiac contractility and fluid status in various cardiovascular disorders. However, to the best of our knowledge, few study has been reported to evaluate the consistency of this technique in cardiac surgery patients. The aim of this study is to evaluate the tracking ability of CO changes measured by continuous carotid doppler technique in cardiac surgery patients, use the thermodilution technique as the referenced.
- Conditions
- Cardiac Surgery
- Being tested
- passive leg raising, Dobutamine
- Keywords
- carotid doppler; hemodynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
passive leg raisingBehavioural
transfer a patient from semi-recumbent position to supine position with a 45° leg lifting
DobutamineDrug
infusion dobutamine
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgery patients with thermodilution technique monitoring | Experimental | Not described Receives: Behavioral: passive leg raising; Drug: Dobutamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output by thermodilution method
measuring cardiac output using thermodilution method
Measured: 5 minutes after the patients was sedated
cardiac output by continuous carotid doppler blood flow
measuring cardiac output using continuous carotid doppler blood flow
Measured: 5minutes after the patients was sedated
cardiac output by thermodilution method
measuring cardiac output using thermodilution method
Measured: 2 minutes after passive leg raising
cardiac output by continuous carotid doppler blood flow
measuring cardiac output using continuous carotid doppler blood flow
Measured: 2 minutes after passive leg raising
cardiac output by thermodilution method
measuring cardiac output using thermodilution method
Measured: 15 minutes after termination of passive leg raising
cardiac output by continuous carotid doppler blood flow
measuring cardiac output using continuous carotid doppler blood flow
Measured: 15 minutes after termination of passive leg raising
cardiac output by thermodilution method
measuring cardiac output using thermodilution method
Measured: 30 minutes after dobutamine infusion
cardiac output by continuous carotid doppler blood flow
measuring cardiac output using continuous carotid doppler blood flow
Measured: 30 minutes after dobutamine infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start31 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhe Luo, Study chair, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05944146
- Sponsor's protocol ID
- Cracard
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hao GW, Huang DL, Ma GG, Su Y, Hou JY, Zhang YJ, Liu WJ, Lu ZH, Luo Z, Tu GW. Ability of the continuous carotid Doppler patch to track directional changes in cardiac output in cardiac surgery patients. Eur J Med Res. 2026 Feb 24. doi: 10.1186/s40001-026-04034-3. Online ahead of print.
PubMed 41736158
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Consistency of Tracking Changes of Cardiac Output by Carotid Doppler Blood Flow and Thermodilution Technique in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT05944146
- Acronym / sponsor ID
- Cracard
- Conditions
- Cardiac Surgery
- Keywords
- carotid doppler; hemodynamic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jul 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.
Currently, the gold standard method to estimate CO is the thermodilution technique, pulmonary artery catheter (PAC) and PiCCO system included, however, the invasiveness and complexity of the thermodilution technique have limited their usefulness in many clinical scenarios. By measuring the carotid blood flow, continuous carotid doppler technique has been reported to noninvasively estimate cardiac output (CO) and other parameters related to cardiac contractility and fluid status in various cardiovascular disorders. However, to the best of our knowledge, few study has been reported to evaluate the consistency of this technique in cardiac surgery patients. The aim of this study is to evaluate the tracking ability of CO changes measured by continuous carotid doppler technique in cardiac surgery patients, use the thermodilution technique as the referenced.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery patients with thermodilution technique monitoring | Experimental | Behavioral: passive leg raising, Drug: Dobutamine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult cardiac surgery patients
- with thermodilution technique monitoring
- mechanical ventilation
Key exclusion criteria (4 listed)
- life threatening arrhythmia
- severe valve regurgitation
- left ventricular ejection fraction less than 30%
- patients with mechanical circulatory support
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 raisingtransfer a patient from semi-recumbent position to supine position with a 45° leg lifting | Behavioural | cardiac surgery patients with thermodilution technique monitoring |
| Dobutamineinfusion dobutamine | Drug | cardiac surgery patients with thermodilution technique monitoring |
Primary outcome
cardiac output by thermodilution method
Time frame: 5 minutes after the patients was sedated
measuring cardiac output using thermodilution method
cardiac output by continuous carotid doppler blood flow
Time frame: 5minutes after the patients was sedated
measuring cardiac output using continuous carotid doppler blood flow
cardiac output by thermodilution method
Time frame: 2 minutes after passive leg raising
measuring cardiac output using thermodilution method
cardiac output by continuous carotid doppler blood flow
Time frame: 2 minutes after passive leg raising
measuring cardiac output using continuous carotid doppler blood flow
cardiac output by thermodilution method
Time frame: 15 minutes after termination of passive leg raising
measuring cardiac output using thermodilution method
cardiac output by continuous carotid doppler blood flow
Time frame: 15 minutes after termination of passive leg raising
measuring cardiac output using continuous carotid doppler blood flow
cardiac output by thermodilution method
Time frame: 30 minutes after dobutamine infusion
measuring cardiac output using thermodilution method
cardiac output by continuous carotid doppler blood flow
Time frame: 30 minutes after dobutamine infusion
measuring cardiac output using continuous carotid doppler blood flow
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Derived from this study: PubMed 41736158Hao GW, Huang DL, Ma GG, Su Y, Hou JY, Zhang YJ, Liu WJ, Lu ZH, Luo Z, Tu GW. Ability of the continuous carotid Doppler patch to track directional changes in cardiac output in cardiac surgery patients. Eur J Med Res. 2026 Feb 24. doi: 10.1186/s40001-026-04034-3. Online ahead of print.
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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.
Zhe Luo 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 in people with Cardiac Surgery, 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: looking for participants now, as of the sponsor's last update on 13 Jul 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guang-wei Hao (02164041990, hao.guangwei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac output by thermodilution method (time frame: 5 minutes after the patients was sedated). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05944146, which also lists 1 linked publication.
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 13 Jul 2023.