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…
ID
Source
Brief title
Condition
- Coronary artery disorders
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
Change in fibrin network formation, platelet aggregation, endothelial function,
fybrinolysis and red blood cell deformability.
Background summary
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.
Study objective
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
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.
Study burden and risks
Surgery: Both types of surgery 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: A total of 112 ml of extra blood will be
sampled during CABG surgery and ICU admission from an existing intra-arterial
line. Blood drawing is performed while the patient is under anesthesia, and
will not add up to patient discomfort in the present study.
De Boelelaan 1117
1081 HV
NL
De Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
Patients undergoing coronary artery bypass graft (CABG) surgery
Age 40-85 years
Informed consent
Exclusion criteria
Re-operations and emergency operations
Patients with insulin-dependent diabetes mellitus
Patients with a body mass index (BMI) > 35 kg/m²
Patients with anemia (Hb <5.5 mmol/l)
Design
Recruitment
Medical products/devices used
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 | NL34947.029.10 |