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

Completed

• Conditions: Heart Valve Surgery

• Registration Number: NCT05136001
• Lead Sponsor: China Medical University, China

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.

Study Timeline

• Study First Submitted: 2021-11-06
• Study Start: 2021-11-08
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-26
• Primary Completion: 2022-07-10
• Study Completion: 2022-08-10
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-21
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
gut microbiota	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

Secondary Outcome Measures

Name	Time	Method
serum metabolites	from baseline to postoperative 72 hours	This study will characterize the serum metabolites in one group of 36 patients before and after heart valve surgery
postoperative sleep	on the second postoperative night from 20:00 to 6:00	This study will characterize the postoperative sleep measured by polysomnography in one group of 36 patients after heart valve surgery

Trial Locations

Locations (1)

the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China