Patients After Cardiac SurgeryNCT04461743
Microcirculation Evolution in Patients After Cardiac Surgery
An observational study of Patients After Cardiac Surgery, run by Southeast University, China at 1 site in China.
Trial summary
We evaluated the impact on macrocirculatory hemodynamics and microcirculation in patients after cardiac surgery and compared the evolutions of those parameters between patients with tissue hypoperfusion and normal perfusion. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Patients After Cardiac Surgery
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 4 Jun 2020to 31 Jan 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients after cardiac surgery who required mechanical ventilation and for whom sublingual microcirculation measurements were possible.
Who may be able to join
- Consecutive patients after cardiac surgery.
- Patients whom sublingual microcirculation measurements were possible.
Who cannot join
- moribund patients
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Critical Care Medicine
Nanjing, Jiangsu, 210009
Jingyuan Xu, Dr
About this study
We evaluated the impact on macrocirculatory hemodynamics and microcirculation in patients after cardiac surgery and compared the evolutions of those parameters between patients with tissue hypoperfusion and normal perfusion. Consecutive patients after cardiac surgery who required mechanical ventilation and for whom sublingual microcirculation measurements were possible enrolled.
Read the detailed description
We evaluated the impact on macrocirculatory hemodynamics and microcirculation in patients after cardiac surgery and compared the evolutions of those parameters between patients with tissue hypoperfusion and normal perfusion.
- Conditions
- Patients After Cardiac Surgery
- Being tested
- No intervention
- Keywords
- microcirculation, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention, regular therapy
| Study group | Role | What they receive |
|---|---|---|
| Patients with normal lac | Not described Receives: Other: No intervention | |
| Patients with abnormal lac | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microcirculation
PPV and MFI
Measured: Extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start4 Jun 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients After Cardiac SurgeryStudies 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
- Prospective
- Enrolment
- 40 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, Principal investigator, Southeast University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461743
- Sponsor's protocol ID
- 2020
- Status last verified
- Jul 2020
- First submitted
- 31 May 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcirculation Evolution in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04461743
- Acronym / sponsor ID
- 2020
- Conditions
- Patients After Cardiac Surgery
- Keywords
- microcirculation, cardiac surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 8 Jul 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.
We evaluated the impact on macrocirculatory hemodynamics and microcirculation in patients after cardiac surgery and compared the evolutions of those parameters between patients with tissue hypoperfusion and normal perfusion. Consecutive patients after cardiac surgery who required mechanical ventilation and for whom sublingual microcirculation measurements were possible enrolled.
Detailed description
We evaluated the impact on macrocirculatory hemodynamics and microcirculation in patients after cardiac surgery and compared the evolutions of those parameters between patients with tissue hypoperfusion and normal perfusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with normal lac | – | Other: No intervention |
| Patients with abnormal lac | – | Other: No intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients after cardiac surgery who required mechanical ventilation and for whom sublingual microcirculation measurements were possible.
Key inclusion criteria (2 listed)
- Consecutive patients after cardiac surgery.
- Patients whom sublingual microcirculation measurements were possible.
Key exclusion criteria (1 listed)
- moribund patients
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 |
|---|---|---|
| No interventionNo intervention, regular therapy | Other | Patients with abnormal lac, Patients with normal lac |
Primary outcome
Microcirculation
Time frame: Extubation
PPV and MFI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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 principal investigator
Southeast University
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 Patients After Cardiac Surgery, 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 2 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 8 Jul 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 Jingyuan Xu (8613851417209, xujingyuanmail@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microcirculation (time frame: Extubation). 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 8 Jul 2020.