The aim of the study is to evaluate the effect of warm blood cardioplegia administration without rollerpump on perioperative myocardial injury in patients undergoing coronary artery bypass grafting (CABG) with a minimal extracorporeal circuit (MECC…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Perioperative myocardial injury, reflected by biomarker release:
- Troponin I
- hFABP
- NT-pro-BNP
Secondary outcome
- Post-operative myocardial infarction: rise of troponin above the 99th
percentile together with evidence of myocardial ischaemia (symptoms of
ischaemia or ECG changes)
- Cardioplegia bloodflow measured with Em-Tec
- Pressure in aortic root during blood cardioplegia administration
- Line pressure cardioplegia
- Total Potassium chloride/Magnesium sulfaat (ml)
- Serum potassium level patient after aortic declamping
- Longest interval of blood cardioplegia (min)
- Mean interval of blood cardioplegia (min)
- ECG activity during aortic occlusion
- Number of blood cardioplegia gifts
- Intra-operative inflammatory respons, refelcted bij CRP level.
- Number of anastomosis
- ECC time (min)
- Aortic occlusion time (min)
- Number of defibrillation after aortic declamping
- Inotropic support (hours)
- Post-operative complications (TIA/CVA, pneumonia, renal failure
(createnine>177), re-thoracotomy, atrial fibrillation)
- Length of ICU stay
- Length of hospital stay
Background summary
Over the last decade, warm blood cardioplegia is infused with a roller pump
according to the modified calafiori technique. Blood cardioplegia can also be
delivered without the use of a roller pump, but with the use of the arterial
line pressure as created by the arterial centrifugal pump of the
cardiopulmonary bypass system. This technique is currently applied in some
clinics in the Netherlands and probably in more clinics world-wide. The
elimination of a roller pump might be a step towards the reduction of
heart-lung machine hardware. The use of a mini heart-lung machine may become
available for future use in cardiac surgery. Besides the avoidance of a roller
pump, an advantage of this method may be that the flow of the blood cardiolegia
will be dynamic. The flow of the blood cardioplegia will be influenced by the
functional status and the size of the patients* heart.
Study objective
The aim of the study is to evaluate the effect of warm blood cardioplegia
administration without rollerpump on perioperative myocardial injury in
patients undergoing coronary artery bypass grafting (CABG) with a minimal
extracorporeal circuit (MECC).
Study design
The design of the study is a randomized controlled trial.
Intervention
After informed consent, patients will be randomized into study group (blood
cardioplegia administation without roller pump) or control group (blood
cardioplegia administration with roller pump).
Study burden and risks
There is no expected associated risk with participation in this study. Both
administration techniques of warm blood cardioplegia are standard treatments
and are successfully performed world wide. Blood samples will be taken after
anaesthetic induction (T0), after arrival ICU (T1), 4 hours in ICU (T2) and
first day post-operative (T3). The patient*s discomfort is therefore limited.
Patrijzenhof 102
3755 EV Eemnes
NL
Patrijzenhof 102
3755 EV Eemnes
NL
Listed location countries
Age
Inclusion criteria
- Patients undergoing elective coronary artery bypass grafting
- At least 3 distal anastomosis will be performed
Exclusion criteria
- Previous cardiac surgery
- Left ventricular ejection fraction <45%
- Chronic renal failure, defined by preoperative creatinine > 177 ug/ml.
- Aortic Insufficiency, >= grade 1
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40335.100.12 |