Study Results
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Basic Information
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NOT_YET_RECRUITING
122 participants
OBSERVATIONAL
2025-10-01
2026-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1: 61 patients undergoing CABG will have a posterior pericardial window created for drainage.
Based on determining the main outcome variable, the estimated minimum required sample size is 122 patients (61 patients in each group).
* Group I (Posterior Pericardial Window group): 61 patients undergoing CABG will have a posterior pericardial window created for drainage.
* Group II (Retro-cardiac Drain group): 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage.
No interventions assigned to this group
Group 2 : 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage.
Based on determining the main outcome variable, the estimated minimum required sample size is 122 patients (61 patients in each group).
* Group I (Posterior Pericardial Window group): 61 patients undergoing CABG will have a posterior pericardial window created for drainage.
* Group II (Retro-cardiac Drain group): 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ahmed Mohamed Saad Abdelhamid
Principal Investigator
Central Contacts
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References
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Aranki SF, Shaw DP, Adams DH, Rizzo RJ, Couper GS, VanderVliet M, Collins JJ Jr, Cohn LH, Burstin HR. Predictors of atrial fibrillation after coronary artery surgery. Current trends and impact on hospital resources. Circulation. 1996 Aug 1;94(3):390-7. doi: 10.1161/01.cir.94.3.390.
Kalavrouziotis D, Buth KJ, Ali IS. The impact of new-onset atrial fibrillation on in-hospital mortality following cardiac surgery. Chest. 2007 Mar;131(3):833-839. doi: 10.1378/chest.06-0735.
Almassi GH, Schowalter T, Nicolosi AC, Aggarwal A, Moritz TE, Henderson WG, Tarazi R, Shroyer AL, Sethi GK, Grover FL, Hammermeister KE. Atrial fibrillation after cardiac surgery: a major morbid event? Ann Surg. 1997 Oct;226(4):501-11; discussion 511-3. doi: 10.1097/00000658-199710000-00011.
Mathew JP, Fontes ML, Tudor IC, Ramsay J, Duke P, Mazer CD, Barash PG, Hsu PH, Mangano DT; Investigators of the Ischemia Research and Education Foundation; Multicenter Study of Perioperative Ischemia Research Group. A multicenter risk index for atrial fibrillation after cardiac surgery. JAMA. 2004 Apr 14;291(14):1720-9. doi: 10.1001/jama.291.14.1720.
Maisel WH, Rawn JD, Stevenson WG. Atrial fibrillation after cardiac surgery. Ann Intern Med. 2001 Dec 18;135(12):1061-73. doi: 10.7326/0003-4819-135-12-200112180-00010.
Xiong T, Pu L, Ma YF, Zhu YL, Li H, Cui X, Li YX. Posterior pericardiotomy to prevent new-onset atrial fibrillation after coronary artery bypass grafting: a systematic review and meta-analysis of 10 randomized controlled trials. J Cardiothorac Surg. 2021 Aug 14;16(1):233. doi: 10.1186/s13019-021-01611-x.
Ranjan R, Kapetanakis S, Chandrasekaran V, Kaba RA, Momin AU. Posterior Pericardial Window and a Single Pleural Drain: A Dual Defence Against Post-CABG Pericardial Effusion and Atrial Fibrillation. Ther Clin Risk Manag. 2025 Apr 15;21:481-487. doi: 10.2147/TCRM.S521874. eCollection 2025.
Other Identifiers
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Drainage technique in CABG
Identifier Type: -
Identifier Source: org_study_id
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