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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05136001
Recruitment Status : Recruiting
First Posted : November 26, 2021
Last Update Posted : November 26, 2021
Sponsor:
Information provided by (Responsible Party):
Wen-fei Tan, China Medical University, China

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.

Condition or disease Intervention/treatment
Heart Valve Surgery Device: polysomnography

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.

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Study Type : Observational
Estimated Enrollment : 36 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Characterizations of Gut Microbiota and Postoperative Sleep in Patients Undergoing Heart Valve Surgery With Cardiopulmonary Bypass
Actual Study Start Date : November 8, 2021
Estimated Primary Completion Date : July 10, 2022
Estimated Study Completion Date : August 10, 2022

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


Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
gut microbiota and serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05136001


Locations
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China, Liaoning
the First Hospital of China Medical University Recruiting
Shenyang, Liaoning, China, 110001
Contact: Wenfei Tan, M.D.,Ph.D    024-83283100    winfieldtan@hotmail.com   
Sponsors and Collaborators
China Medical University, China
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Responsible Party: Wen-fei Tan, Professor, China Medical University, China
ClinicalTrials.gov Identifier: NCT05136001    
Other Study ID Numbers: 2021.09.10-02
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: November 26, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wen-fei Tan, China Medical University, China:
Gut Microbiota
polysomnography