Heart Valve SurgeryNCT05136001
Characterizations of Gut Microbiota and Postoperative Sleep in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
An observational study of Heart Valve Surgery, run by China Medical University, China at 1 site in China.
Trial summary
The investigators designed a study to assess whether there is any change in gut microbiota and postoperative sleep before and after heart valve surgery with cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Valve Surgery
- What is being tested?
- polysomnography
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2021to 10 Aug 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will characterize the gut microbiota and serum metabolites in one group of 36 patients before and after heart valve surgery
Who may be able to join
- Ethnic Chinese;
- Age, 18 to 65 years old;
- Patients undergoing heart valve surgery with cardiopulmonary bypass
Who cannot join
- Preoperative Pittsburgh Sleep Quality Index global scores higher than 6
- Cognitive difficulties
- Partial or complete gastrectomy
- Previous esophageal surgery
- Previous treated by radiotherapy or surgery
- Inability to conform to the study's requirements
Show all 10Show fewer
- Body mass index exceeding 30 kg/m2
- Deprivation of a right to decide by an administrative or juridical entity
- Ongoing participation or participation in another study <1 month ago
- Recent (< 3 months prior) use of antibiotics, probiotics, prebiotics, symbiotics, hormonal medication, laxatives, proton pump inhibitors, insulin sensitizers or traditional Chinese medicine
Trial locations and contacts
1 site in 1 country.
China1 site
the First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
The investigators designed a study to assess whether there is any change in gut microbiota and postoperative sleep before and after heart valve surgery with cardiopulmonary bypass.
Read the detailed description
The investigators designed a study to assess whether there is any change in gut microbiota and postoperative sleep before and after heart valve surgery with cardiopulmonary bypass. Firstly, this study aims to characterize the gut microbiota in patients with valve disease treated with surgery. Secondly, it aims to evaluate microbiota and its influence on postoperative sleep.
- Conditions
- Heart Valve Surgery
- Being tested
- polysomnography
- Keywords
- Gut Microbiota, polysomnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnographyDevice
Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00am).
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiota
This study will characterize the gut microbiota in one group of 36 patients before and after heart valve surgery
Measured: from baseline to postoperative 72 hours
Secondary outcomes (2)
postoperative sleep
This study will characterize the postoperative sleep measured by polysomnography in one group of 36 patients after heart valve surgery
Measured: on the second postoperative night from 20:00 to 6:00
serum metabolites
This study will characterize the serum metabolites in one group of 36 patients before and after heart valve surgery
Measured: from baseline to postoperative 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start8 Nov 2021
- Primary completion10 Jul 2022
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve 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
- Retrospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-fei Tan, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136001
- Sponsor's protocol ID
- 2021.09.10-02
- Status last verified
- Oct 2022
- First submitted
- 6 Nov 2021
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizations of Gut Microbiota and Postoperative Sleep in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05136001
- Acronym / sponsor ID
- 2021.09.10-02
- Conditions
- Heart Valve Surgery
- Keywords
- Gut Microbiota, polysomnography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 26 Nov 2021 (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.
The investigators designed a study to assess whether there is any change in gut microbiota and postoperative sleep before and after heart valve surgery with cardiopulmonary bypass.
Detailed description
The investigators designed a study to assess whether there is any change in gut microbiota and postoperative sleep before and after heart valve surgery with cardiopulmonary bypass. Firstly, this study aims to characterize the gut microbiota in patients with valve disease treated with surgery. Secondly, it aims to evaluate microbiota and its influence on postoperative sleep.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will characterize the gut microbiota and serum metabolites in one group of 36 patients before and after heart valve surgery
Key inclusion criteria (3 listed)
- Ethnic Chinese;
- Age, 18 to 65 years old;
- Patients undergoing heart valve surgery with cardiopulmonary bypass
Key exclusion criteria (10 listed)
- Preoperative Pittsburgh Sleep Quality Index global scores higher than 6
- Cognitive difficulties
- Partial or complete gastrectomy
- Previous esophageal surgery
- Previous treated by radiotherapy or surgery
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 |
|---|---|---|
| polysomnographyDuration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00am). | Device | – |
Primary outcome
gut microbiota
Time frame: from baseline to postoperative 72 hours
This study will characterize the gut microbiota in one group of 36 patients before and after heart valve surgery
2 secondary outcomes
postoperative sleep
Time frame: on the second postoperative night from 20:00 to 6:00
serum metabolites
Time frame: from baseline to postoperative 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Valve Surgery, run by China Medical 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 25 Oct 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gut microbiota (time frame: from baseline to postoperative 72 hours). 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 25 Oct 2022.