Drainage Technique in CABG
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
122 Participants
are grouped into 2 trial groupsGroup A: Group 1: 61 patients undergoing CABG will have a posterior pericardial window created for drainage.
Group B: Group 2 : 61 patients undergoing CABG will receive a retro-cardiac drain for pericardial drainage.
Trial outcomes
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.
Time frame
During hospitalization and up to 3 months after surgerySecondary outcomes
1
Postoperative clinical outcomes (ICU stay, hospital stay, revision surgery, and in-hospital mortality)
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.
Time frame
From surgery until hospital discharge (up to 30 days)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: