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Clinical Trials/NCT05136001
NCT05136001
Completed
Not Applicable

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

China Medical University, China1 site in 1 country36 target enrollmentNovember 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Valve Surgery
Sponsor
China Medical University, China
Enrollment
36
Locations
1
Primary Endpoint
gut microbiota
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 8, 2021
End Date
August 10, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wen-fei Tan

Professor

China Medical University, China

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • serum metabolites(from baseline to postoperative 72 hours)
  • postoperative sleep(on the second postoperative night from 20:00 to 6:00)

Study Sites (1)

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