No registrations found.
ID
Source
Brief title
Health condition
coronary artery bypass graft surgery, pulsatile cardiopulmonary bypass, microcirculatory perfusion, endothelial function, platelet aggregation, fibrinolysis
Sponsors and support
Institute for Cardiovascular Research
Department of Anesthesiology
Intervention
Outcome measures
Primary outcome
Change in microcirculatory perfusion during surgery, sublingual erythrocyte velocity, capillary diameter and capillary density.
Secondary outcome
1. Platelet aggregation;
2. Fibrin formation/degradation;
3. Red blood cell deformability;
4. Endothelial barrier function;
5. Endothelial biomarker expression.
Background summary
Rationale:
Non-pulsatile cardiopulmonary bypass (CPB) during cardiac surgery is associated with postoperative disturbances in microcirculatory perfusion, which are prevented by reinstatement of pulsatile flow. Moreover, impaired microcirculatory perfusion after non-pulsatile flow correlates with the presence of prothrombogenic markers. The question arises whether prothrombogenic alterations are indeed related to disturbances in microcirculatory perfusion, and how this relation is affected by non-pulsatile and pulsatile CPB. Furthermore, it is unknown whether the relation of a prothrombogenic profile with microcirculatory perfusion involves distinct alterations in endothelial function.
Objectives:
We aim to investigate whether pulsatile flow in patients subjected to CPB preserves postoperative microcirculatory perfusion by prevention of a prothrombogenic profile and endothelial activation as are both present under non-pulsatile flow conditions.
Study design:
Single-center prospective, randomized study in the VUmc.
Study population:
Patients undergoing elective coronary bypass graft surgery (CABG; n = 48). Patients will be randomly assigned into two study groups:
1. Non-pulsatile flow: Continuous flow during CPB;
2. Pulsatile flow: Pulsatile flow during CPB.
Intervention:
The intervention consists of the application of one type of cardiopulmonary bypass (conventional or pulsatile CPB). All interventions are part of standard clinical care.
Main study parameters/endpoints:
Change in microcirculatory perfusion, sublingual erythrocyte velocity, capillary diameter and capillary density.
Study objective
Pulsatile flow during cardiopulmonary bypass (CPB) results in preservation of microcirculatory function in the early postoperative period as compared to non-pulsatile CPB.
Study design
Measurements take place during the day of the operation and end within 4 hours after the operation.
Intervention
Pulsatile cardiopulmonary bypass vs. non-pulsatile cardiopulmonary bypass.
Christa Boer
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4443830
c.boer@vumc.nl
Christa Boer
De Boelelaan 1117
Amsterdam 1081 HV
The Netherlands
+31 (0)20 4443830
c.boer@vumc.nl
Inclusion criteria
1. Patients undergoing coronary artery bypass surgery (CABG);
2. Age 40-85 years;
3. Informed consent.
Exclusion criteria
1. Re-operations and emergency operations;
2. Patients with insulin-dependent diabetes mellitus;
3. Patients with a body mass index (BMI) > 35 kg/m2;
4. Patients with anemia (Hb < 5.5 mmol/l).
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 |
---|---|
NTR-new | NL2799 |
NTR-old | NTR2940 |
Other | VUMC Department of anesthesiology : ANES2010/070 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |