Postoperative Atrial Fibrillation in Cardiac Surgery | NCT06958029

Studies
Postoperative Atrial Fibrillation in Cardiac Surgery

NCT06958029

Sponsor

Khon Kaen University

Status

Recruiting

Last Update Posted

May 6, 2025Actual

Enrollment

275Estimated

Phase

Not provided

Conditions

Post-operative Atrial Fibrillation

Interventions

Cardiac surgery

Countries

Thailand

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

ID	Type	Description	Link
Khon Kaen University	Other Identifier	Khon Kaen University

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2025Actual

Primary Completion Date

Jun 1, 2025Estimated

Completion Date

Jun 10, 2025Estimated

First Submitted Date

Apr 27, 2025

First Submission Date that Met QC Criteria

Apr 27, 2025

First Posted Date

May 6, 2025Actual

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

Apr 27, 2025

Last Update Posted Date

May 6, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thepakorn Sathitkarnmanee, Associate professor, Khon Kaen UniversityPrincipal Investigator

Lead Sponsor

Khon Kaen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

This multicenter observational study aims to investigate the incidence and identify risk factors associated with postoperative atrial fibrillation (POAF) in patients undergoing cardiac surgery at three medical centers in Thailand. The study will examine patient characteristics, surgical factors, and anesthetic management practices that may contribute to the development of this common postoperative complication.

Detailed Description

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery, with incidence rates reported between 15-30% after valve surgery and 18-74% after coronary artery bypass grafting. POAF typically occurs within 72 hours after surgery and is associated with increased morbidity, mortality, length of hospital stay, and healthcare costs.

The Society of Thoracic Surgeons has identified five major postoperative complications associated with cardiac surgery, including POAF, which can significantly affect patient outcomes. This multicenter observational study will examine the incidence and risk factors of POAF in cardiac surgery patients across three medical centers in Thailand: Srinagarind Hospital at Khon Kaen University, Northeastern Thailand Cardiac Center, and Surat Thani Hospital.

The study will collect data on patient demographics, comorbidities, preoperative laboratory values, perioperative characteristics, surgical procedures (valve surgery, CABG, combined procedures), and postoperative complications. By identifying risk factors associated with POAF, this study aims to develop preventive strategies and improve management protocols for patients at high risk for this complication.

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

275Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac surgery		Patients undergoing cardiac surgery	Procedure: Cardiac surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac surgery	Procedure	Patients receiving general anesthesia for cardiac surgery	Cardiac surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence	The incidence of POAF	72 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Risk factors	Risk factors associated with POAF	72 hours postoperatively

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18 years
Patients undergoing cardiac valve surgery or coronary artery bypass grafting (CABG) procedures

Exclusion Criteria:

Patients undergoing aortic surgery
Patients undergoing MAZE procedure
Incomplete medical records
Patients who required mechanical circulatory support before surgery
Patients who died during surgery or within 3 days after surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients ubdergoing cardiac surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sirirat Tribuddharat, MD, PhD	Contact	66-81-6205921		sirirat.tribuddharat@gmail.com

Overall Officials

Name	Affiliation	Role
Thepakorn Sathitkarnmanee, MD	Khon Kaen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Khon Kaen University	Recruiting	Khon Kaen		40002	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27884410	Result	Crawford TC, Magruder JT, Grimm JC, Suarez-Pierre A, Sciortino CM, Mandal K, Zehr KJ, Conte JV, Higgins RS, Cameron DE, Whitman GJ. Complications After Cardiac Operations: All Are Not Created Equal. Ann Thorac Surg. 2017 Jan;103(1):32-40. doi: 10.1016/j.athoracsur.2016.10.022. Epub 2016 Nov 22.
18294562	Result

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

ID	Term
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019616	Thoracic Surgical Procedures