CPPF After Cardiac Surgery in High Risk Patients (FLUID)
Cardiac Surgical Procedures, Retained Blood Syndrome, Cardiac Tamponade
About this trial
This is an interventional prevention trial for Cardiac Surgical Procedures focused on measuring Continuous Postoperative Pericardial Flush (CPPF), CABG, Retained Blood Syndrome, Chest tubes [Mesh], Blood Transfusion [mesh], Therapeutic irrigation [Mesh]
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for CABG with continued DAPT
- Patients with aIE scheduled for valve replacement
- Patients scheduled for complex or multiple cardiac (redo) procedures with an (expected) CPB time >300 minutes
- Patients undergoing aortic surgery with DHCA
Exclusion Criteria:
- Euroscore II > 20%
- Intraoperatively diaphragm injury leading to an open connection between the thoracic and abdominal cavity
- Age < 18
- Inability to understand study information
- Participation in any study involving an investigational drug or device
Exclusion criteria specific for the CABG group include:
- Emergency CABG
- Single anti-platelet medication
- Off pump surgery
Exclusion criteria specific for the IE group include:
• Subacute or chronic endocarditis: no signs of ongoing infection under AB treatment.
Exclusion criteria specific for the aortic surgery group include:
- Emergency procedures
- Isolated ascending aorta replacement
Sites / Locations
- Amsterdam UMC
- Catharina Ziekenhuis
- Leiden University Medical Center
- St. Antonius Ziekenhuis
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Continuous Postoperative Pericardial Flushing
Control
Continuous Postoperative Pericardial Flushing (inflow of 500 ml NaCl 0,9% flushing fluid into the pericardial cavity during the first 8 postoperative hours) executed with the Haermonics investigational device
Standard care