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Clinical Trials/NCT07194798
NCT07194798Not yet recruitingNot Applicable

A Prospective Randomized Trial Comparing the Posterior Pericardial Window Versus Retro-Cardiac Drain for the Prevention of Postoperative Atrial Fibrillation and Pericardial Complications Following CABG

Assiut University0 sites122 target enrollmentStarted: October 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
122
Primary Endpoint
Incidence of postoperative atrial fibrillation and pericardial complications

Study Overview

Brief Summary

aims to compare the efficacy of the posterior pericardial window versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, while assessing their impact on hospital and ICU stay, pericardial effusions, re exploration for bleeding, post-operative blood transfusions, and mortality.

Detailed Description

Coronary artery bypass grafting (CABG) is a cornerstone in the management of advanced coronary artery disease, yet it carries a notable risk of postoperative complications. Among these, postoperative atrial fibrillation (POAF) is particularly common, affecting up to 40% of patients and contributing to increased morbidity, prolonged ICU and hospital stays, and elevated healthcare costs.

Pericardial effusion and tamponade are also frequent sequelae after CABG operation, often exacerbating the risk of POAF and necessitating re-intervention. Traditionally, retro-cardiac drains have been used to evacuate pericardial fluid, but their efficacy in preventing effusion-related complications is limited.

The posterior pericardial window (PPW) technique has emerged as a promising alternative, offering improved drainage and reduced incidence of POAF, early and late pericardial effusion, and tamponade. Studies have shown that PPW may also shorten ICU and hospital stays, reduce pleural effusion, and lower the need for revision surgery due to bleeding.

Despite encouraging data, randomized trials directly comparing PPW and retro-cardiac drains remain scarce. This study aims to fill that gap by evaluating the effectiveness of PPW versus retro-cardiac drain in preventing postoperative atrial fibrillation and pericardial complications following CABG, with secondary outcomes including pleural effusion, ICU/hospital stay duration, revision surgery, and mortality.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Adult patients (aged 18 and above) scheduled for elective, first-time coronary artery bypass grafting (CABG).
  • •Patients with preserved left ventricular function (ejection fraction ≥ 35%).
  • •Ability to provide informed consent and comply with follow-up protocols.
  • •No prior history of atrial fibrillation or other significant arrhythmias.

Exclusion Criteria

  • •Patients undergoing combined cardiac procedures (e.g., valve repair or replacement).
  • •Emergency CABG cases or re-operations.
  • •Known bleeding disorders or ongoing anticoagulation therapy that cannot be paused.
  • •Severe pericardial adhesions or anatomical abnormalities preventing safe creation of a posterior pericardial window.
  • •Chronic pulmonary disease or pleural pathology that may interfere with drainage assessment.
  • •Patients with active infections or systemic inflammatory conditions.

Outcomes

Primary Outcomes

Incidence of postoperative atrial fibrillation and pericardial complications

Time Frame: During hospitalization and up to 3 months after surgery

Postoperative atrial fibrillation will be detected by continuous ECG monitoring during hospitalization. Pericardial complications, including early and late pericardial effusion, cardiac tamponade, and pleural effusion, will be assessed using echocardiography. The outcome will be reported as the number and percentage of participants experiencing any of these events.

Secondary Outcomes

  • Postoperative clinical outcomes (ICU stay, hospital stay, revision surgery, and in-hospital mortality)(From surgery until hospital discharge (up to 30 days))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ahmed Mohamed Saad Abdelhamid

Principal Investigator

Assiut University

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