Drainage Technique in CABG

NCT07194798 | Not Yet Recruiting

• 1 other identifier: Drainage technique in CABG
• Study Type: observational
• Target: 122
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CABG; Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative atrial fibrillation and pericardial complications

  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.

  During hospitalization and up to 3 months after surgery

Secondary Outcomes (1)

• Postoperative clinical outcomes (ICU stay, hospital stay, revision surgery, and in-hospital mortality)

  From surgery until hospital discharge (up to 30 days)

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients scheduled to undergo elective, first-time, isolated coronary artery bypass grafting (CABG) surgery via median sternotomy. Eligible participants will be hemodynamically stable and able to provide informed consent prior to enrollment. Patients will be randomized intraoperatively to receive either a posterior pericardial window or a retro-cardiac drain for postoperative management.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (7)

• 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.

  PMID: 8759081 BACKGROUND

• 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.

  PMID: 17356100 BACKGROUND

• 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.

  PMID: 9351718 BACKGROUND

• 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.

  PMID: 15082699 BACKGROUND

• 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.

  PMID: 11747385 BACKGROUND

• 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.

  PMID: 34391454 BACKGROUND

• 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.

  PMID: 40255667 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ahmed mohamed saad, Principal Investigator

CONTACT

+201014570052; Ahmed.17289818@med.aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 19, 2025
• First Posted: September 26, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09