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CompletedNCT05136001Updated Oct 25, 2022

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

An observational study in Heart Valve Surgery, sponsored by China Medical University, China. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-10-25.

Sponsored by China Medical University, China · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
36
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Heart Valve Surgery

Keywords

  • Gut Microbiota
  • polysomnography
03

In context

Lead sponsor

China Medical University, China is the lead sponsor of 93 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
36 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Devicepolysomnography

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

06

What researchers measure

Primary outcomes

  1. gut microbiota

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

    Time frame: from baseline to postoperative 72 hours

Secondary outcomes

  1. postoperative sleep

    This study will characterize the postoperative sleep measured by polysomnography in one group of 36 patients after heart valve surgery

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

  2. serum metabolites

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

    Time frame: from baseline to postoperative 72 hours

07

Study locations

1 site
  • the First Hospital of China Medical University
    Shenyang, Liaoning 110001, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05136001
Lead sponsor
China Medical University, China
Responsible party
Wen-fei Tan (Professor, China Medical University, China) — Principal investigator
First posted
Nov 26, 2021
Start date
Nov 8, 2021
Primary completion
Jul 10, 2022
Completion
Aug 10, 2022
Last update
Oct 25, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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