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Drainage Technique in CABG

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07194798
Enrollment
122
Registered
2025-09-26
Start date
2025-10-01
Completion date
2026-12-01
Last updated
2025-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation (AF), CABG

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of postoperative atrial fibrillation and pericardial complicationsDuring hospitalization and up to 3 months after surgeryPostoperative 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

MeasureTime frameDescription
Postoperative clinical outcomes (ICU stay, hospital stay, revision surgery, and in-hospital mortality)From surgery until hospital discharge (up to 30 days)Postoperative outcomes will include: Length of ICU stay and total hospital stay (measured in days from surgery until discharge). Requirement for revision surgery due to bleeding (documented from operative and postoperative records). All-cause in-hospital mortality (death from any cause during index hospitalization). These outcomes will be reported as duration in days and/or number and percentage of participants, as appropriate.

Contacts

Primary ContactAhmed mohamed saad, Principal Investigator
Ahmed.17289818@med.aun.edu.eg+201014570052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026