Characterizations of Gut Microbiota and Postoperative Sle... | NCT05136001

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

NCT05136001

Sponsor

China Medical University, China

Status

Completed

Last Update Posted

Oct 25, 2022Actual

Enrollment

36Actual

Phase

Not provided

Conditions

Heart Valve Surgery

Interventions

polysomnography

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 8, 2021Actual

Primary Completion Date

Jul 10, 2022Actual

Completion Date

Aug 10, 2022Actual

First Submitted Date

Nov 6, 2021

First Submission Date that Met QC Criteria

Nov 16, 2021

First Posted Date

Nov 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 21, 2022

Last Update Posted Date

Oct 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
polysomnography	Device	Duration of sleep was collected with polysomnography on second postoperative night. (from 20:00pm to 06:00am).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
postoperative sleep	This study will characterize the postoperative sleep measured by polysomnography in one group of 36 patients after heart valve surgery	on the second postoperative night from 20:00 to 6:00
serum metabolites

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the First Hospital of China Medical University		Shenyang	Liaoning	110001	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017286	Polysomnography

Ancestor Terms

ID	Term
D008991	Monitoring, Physiologic
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided