To identify the influence of two different biocompatible-coated extracorporeal circuits on the perfused boundary region of the sublingual microvasculature as measured by the GlycoCheck Sidestream Darkfield Imaging camera.
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Perioperative changes in the perfused boundary region of the sublingual
microvasculature.
Secondary outcome
Shedding of Syndecan-1, heparan sulphate and hyaluronic acid.
Background summary
The endothelial glycocalyx (EGC) is a gel-like layer that acts as a natural
coating for endothelial cells, thereby preventing these cells from having
direct contact with circulating blood cells. In order to reduce the
inflammatory and procoagulant response during cardiopulmonary bypass in
patients undergoing cardiac surgery through contact activation, extracorporeal
circuits are coated with a biocompatible surface. In VU University Medical
Center, cardiopulmonary bypass is mostly performed using a heparin-coated
extracorporeal circuit in combination with full anticoagulation by heparin
infusion. Alternatively, a phosphorylcholine-coated extracorporeal circuit is
used, but it is unknown how these different biocompatible-coated extracorporeal
circuits will contribute to the preservation of the glycocalyx during cardiac
surgery.
Study objective
To identify the influence of two different biocompatible-coated extracorporeal
circuits on the perfused boundary region of the sublingual microvasculature as
measured by the GlycoCheck Sidestream Darkfield Imaging camera.
Study design
Single-center prospective, randomized study in the VU University Medical
Center.
Study burden and risks
Both extracorporeal circuits are part of daily clinical care during
cardiothoracic surgery and will not add up to patient risk and burden.
Intravital microscopic imaging of the sublingual microvasculature by means of
the GlycoCheck is a noninvasive measurement and will take before, during and up
to 72 hours following surgery. A total of 80 ml of extra blood will be drawn
from an existing intra-arterial line while the patient is under anesthesia. The
intra-arterial line is part of routine clinical care in cardiac surgery, and
will therefore not add up to patient discomfort in the present study.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
Adult patients undergoing CABG surgery (age 18-85 years)
Informed consent
Exclusion criteria
* Re-operation
* Emergency operation
* Patients with diabetes mellitus type I
* Patients with a history of hematologic or hepatic disease or renal replacement therapy
* Patients with Body Mass Index (BMI) over 35 kg/m2
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
In other registers
Register | ID |
---|---|
CCMO | NL45828.029.13 |
OMON | NL-OMON21929 |