Relationship Between Postoperative Delirium and Heart Fun... | NCT05211934

Studies
Relationship Between Postoperative Delirium and Heart Function in Valvular Surgery

NCT05211934

Sponsor

Beijing Anzhen Hospital

Status

Unknown status

Last Update Posted

Jan 27, 2022Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Valvular Surgery

Interventions

No intervention

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

Jan 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Jul 1, 2024Estimated

Completion Date

Jul 1, 2024Estimated

First Submitted Date

Jan 14, 2022

First Submission Date that Met QC Criteria

Jan 14, 2022

First Posted Date

Jan 27, 2022Actual

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

Jan 14, 2022

Last Update Posted Date

Jan 27, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun Ma, The chief of department of anesthesiology, Beijing Anzhen HospitalPrincipal Investigator

Lead Sponsor

Beijing Anzhen HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Delirium is an acute brain lesion characterized by abnormalities of consciousness, attention, cognition and sensation. Many brain diseases such as stroke, traumatic brain injury and intracranial hypertension can lead to cardiac insufficiency, arrhythmia and heart failure. The incidence of postoperative delirium in patients undergoing cardiac surgery is high. Postoperative delirium is a manifestation of brain function injury. The effect of postoperative delirium on postoperative cardiac function in patients undergoing cardiac surgery is worthy of further discussion.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
The group with delirium			Other: No intervention
The group without delirium			Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention	The group with delirium The group without delirium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
heart function	Doses of norepinephrine, epinephrine, dopamine, dobutamine and vasopressin	up to 60 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing valvular surgery
Age between 60 to 75

Exclusion Criteria:

Have a history of cerebral infarction before operation
Cardiac function was seriously impaired before surgery
Neuropsychiatric disorders were present before surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing valvular surgery in our hospital were selected. The age was 60 years ≤ age ≤75 years, and gender was not limited. According to the occurrence of postoperative delirium, the patients were divided into postoperative delirium group and Non-postoperative delirium group.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Ma	Contact	13370103571		majun7689@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Anzhen hospital, Beijing	Recruiting	Beijing	Beijing Municipality	100029	China