Does CPB affect microcirculatory function by comparing on-pump (CON-CPB) and off-pump (OFF-PUMP) cardiothoracic surgery?Does pulsatile flow during cardiopulmonary bypass (PULSE-CPB) improve microcirculatory function as compared to continuous flow (…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in microcirculatory perfusion, sublingual erythrocyte velocity,
capillary diameter and capillary density.
Secondary outcome
Blood samples (in total 50 ml): creatinine, CK-MB, lactate, pH, HCO3-,
nitrite/nitrate, prostacyclin, angiotensin II, IL-6, IL-10, TNF-alpha, free
hemoglobin.
Urine output, fluid balance, hemodynamic variables, left ventricle function,
venous saturation, need for intra-aortic balloon pump, need for inotropic
medication, ventilation time.
Preoperative: demographic variables, left-ventricle function, serum creatinine,
Euroscore (cardiac operative risk evaluation).
Intraoperative: number of anastomoses, bypass-time, cross-clamp time, pump flow
during CPB, temperature during CPB, MAP during CPB, energy equivalent pressure
during CPB.
Microcirculation measurement during ICU admission.
Background summary
Patients undergoing cardio-thoracic surgery are connected to a heart-lung
machine and subsequently subjected to cardiopulmonary bypass (CBP) in order to
bypass heart and lungs. Although CPB in major resembles body physiology, there
are indications that the use of a heart-lung machine coincides with a reduced
perfusion of the microvasculature. This may result in hypo-oxygenation of
peripheral tissue and an impropriate removal of metabolites. There are
indications that the use of pulsatile flow during CPB, which resembles
circulation physiology, may improve microcirculatory perfusion during cardiac
surgery. Here we aim to investigate the effect of pulsatile CPB (PULSE-CPB) on
microcirculatory perfusion in comparison with conventional and mini-CPB
(CON-CPB and MINI-CPB) and off-pump surgery (OFF-PUMP). Our investigation may
contribute to optimalization of CPB techniques during cardio-thoracic surgery.
Study objective
Does CPB affect microcirculatory function by comparing on-pump (CON-CPB) and
off-pump (OFF-PUMP) cardiothoracic surgery?
Does pulsatile flow during cardiopulmonary bypass (PULSE-CPB) improve
microcirculatory function as compared to continuous flow (CON-CPB) or a
mini-CPB (MINI-CPB) system?
Study design
Single-center prospective, randomized study in the VUmc
Study burden and risks
All described types of surgery (on-pump and off-pump) are routinely used during
cardiothoracic surgery and will not add up to patient risk and burden.
SDF-imaging
Sublingual measurements of the microcirculation will be performed, meaning that
the SDF-device has to be partially placed intra-oral. Since this is a
non-invasive procedure, which is only performed during anesthesia, the burden
for patients is considered minimal.
Blood sampling
Extra blood (50 ml) will be sampled during CABG surgery from the CPB blood
container while the patient is under anesthesia. The first 25 ml will be drawn
before onset of CPB, the second 25 ml just after removing the aortic cross
clamp. Since blood drawing is performed while the patient is under anesthesia,
this will not add up to patient discomfort in the present study.
De Boelelaan 1117
1081 HV
Nederland
De Boelelaan 1117
1081 HV
Nederland
Listed location countries
Age
Inclusion criteria
Patients undergoing CABG surgery
Age 18-85 years
Informed consent
Exclusion criteria
Re-operations
Emergency operation
Patients with insulin-dependent diabetes mellitus
Patients with Body Mass Index (BMI) over 30 kg/m2
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 | NL24707.029.08 |