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

NCT ID: NCT05136001

Last Updated: 2022-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-08

Study Completion Date

2022-08-10

Brief Summary

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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

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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

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Heart Valve Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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polysomnography

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Wen-fei Tan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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the First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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2021.09.10-02

Identifier Type: -

Identifier Source: org_study_id

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