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Characterizations of Gut Microbiota and Postoperative Sleep in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass

Characterizations of Gut Microbiota and Postoperative Sleep in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05136001
Enrollment
36
Registered
2021-11-26
Start date
2021-11-08
Completion date
2022-08-10
Last updated
2022-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Valve Surgery

Keywords

Gut Microbiota, polysomnography

Brief 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.

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.

Interventions

DEVICEpolysomnography

Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00am).

Sponsors

China Medical University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Ethnic Chinese; * Age, 18 to 65 years old; * Patients undergoing heart valve surgery with cardiopulmonary bypass

Exclusion criteria

* 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 * 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

Design outcomes

Primary

MeasureTime frameDescription
gut microbiotafrom baseline to postoperative 72 hoursThis study will characterize the gut microbiota in one group of 36 patients before and after heart valve surgery

Secondary

MeasureTime frameDescription
postoperative sleepon the second postoperative night from 20:00 to 6:00This study will characterize the postoperative sleep measured by polysomnography in one group of 36 patients after heart valve surgery
serum metabolitesfrom baseline to postoperative 72 hoursThis study will characterize the serum metabolites in one group of 36 patients before and after heart valve surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026