Skip to main content
OpenTrials
Completed

NCT Number: NCT05136001

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Valve Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Device

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

Primary outcomes

  1. 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

  1. postoperative sleep

    Time frame: 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

  2. serum metabolites

    Time frame: 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

Sponsors and collaborators

Lead sponsor

China Medical University, China

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 26, 2021
Registry last updated
Oct 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.