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

NCT05136001 | Completed DMC

• 1 other identifier: 2021.09.10-02
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Valve Surgery

Keywords

Gut Microbiota; polysomnography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• postoperative sleep

  on the second postoperative night from 20:00 to 6:00

• serum metabolites

  from baseline to postoperative 72 hours

Interventions

polysomnography DEVICE

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will characterize the gut microbiota and serum metabolites in one group of 36 patients before and after heart valve surgery

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University, China: lead

Study Sites (1)

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

gut microbiota and serum

MeSH Terms

Interventions

Polysomnography

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: November 26, 2021
• Study Start: November 8, 2021
• Primary Completion: July 10, 2022
• Study Completion: August 10, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

CN (1)