No registrations found.
ID
Source
Brief title
Health condition
Postoperative blood loss, Cardiac tamponade, Transfusion requirements, Surgical reexploration
Sponsors and support
Intervention
Outcome measures
Primary outcome
1: Mediastinal chest tube drainage (MCTD) 12 hours postoperatively.
2: The difference in hemoglobin levels between the start of CPPF and 12 hours postoperative (ΔHb).
Secondary outcome
Cardiac tamponade, Transfusion requirements, Surgical reexploration, Postoperative atrial fibrillation, sternal wound infection, mediastinitis, Length of ICU stay and hospitalization, Pericardial and/or pleural effusion at discharge, In-hospital mortality, Mortality, Right ventricular function at six months postoperatively
Study objective
Continuous postoperative pericardial flush (CPPF) with a crystalloid is likely to enhance the evacuation of activated and contaminated pericardial blood and cloths out of the pericardial cavity and may contribute to a reduction of (excessive) blood loss and here related transfusion requirements and need for re-operation for bleeding after cardiac surgery. Flushing the pericardial cavity is likely to reduce the amount of cloths and old blood remains after removal of the chest tubes and consequently, the incidence of early and late cardiac effusions and tamponade may be reduced.
Study design
T-1 = Randomization, T0 = Arrival on ICU, T12 = 12 hours postoperatively, T24 = 24 hours postoperatively, TD = Discharge from hospital, T6m = Follow-up six months postoperatively.
Intervention
CPPF will be performed continuously after operation (using a flushing system with a set flow rate of 500ml/hour), starting from the moment the sternum is closed until the total flushing volume of 7000ml has been completely infused.
Johan S.J. Manshanden
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
T +31 (0) 20 - 566 81 88
j.s.manshanden@amc.uva.nl
Johan S.J. Manshanden
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
T +31 (0) 20 - 566 81 88
j.s.manshanden@amc.uva.nl
Inclusion criteria
All adult patients undergoing surgery for CHD and all adult patients undergoing valvular surgery. Valvular surgery includes single and multiple-valve procedures that involve replacement and/or repair of the aortic-, pulmonary-, mitral- and/or tricuspid valve.
Exclusion criteria
Patients are not eligible for this study if the following criteria apply:
- Inability to understand study information and/or give informed consent;
- Emergency surgery;
- Indication for treatment with statins based on the CBO-guideline for cardiovascular risk management;
- Myopathia;
- Participation in any study involving an investigational drug or device;
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5070 |
| NTR-old | NTR5201 |
| CCMO | NL42595.018.12 |
| OMON | NL-OMON39811 |