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

Heart Valve Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05136001
• Other study ID #: 2021.09.10-02
• Status: Completed
• Start date: November 8, 2021
• Est. completion date: August 10, 2022

Study information

• Verified date: October 2022
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 10, 2022
• Est. primary completion date: July 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Valve Surgery

Intervention

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

Locations

Country	Name	City	State
China	the First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gut microbiota	This study will characterize the gut microbiota in one group of 36 patients before and after heart valve surgery	from baseline to postoperative 72 hours
Secondary	postoperative sleep	This study will characterize the postoperative sleep measured by polysomnography in one group of 36 patients after heart valve surgery	on the second postoperative night from 20:00 to 6:00
Secondary	serum metabolites	This study will characterize the serum metabolites in one group of 36 patients before and after heart valve surgery	from baseline to postoperative 72 hours