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Perioperatieve veranderingen in de microvasculaire perfusie in patiŽnten die coronaire bypass chirurgie ondergaan.


- candidate number15566
- NTR NumberNTR4212
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-okt-2013
- Secondary IDsCCH2013-291 / NL45828.029.13 VU University Medical Center / ABR
- Public TitlePerioperatieve veranderingen in de microvasculaire perfusie in patiŽnten die coronaire bypass chirurgie ondergaan.
- Scientific TitlePerioperative changes in the microvascular perfused boundary region in patients undergoing coronary artery bypass grafting.
- ACRONYMGlyCar study
- hypothesisThe primary endpoint of this study is the change in perfused boundary region (PBR) during cardiopulmonary bypass (CPB). We assume that a heparin coated extracorporeal circuit, due to its comparable biochemical structure, is more biocompatible with the endothelial glycocalyx. Hence, the increase of PBR will be more pronounced with the use of a phosphorylcholine-coated extracorporeal circuit. Therefore, it is hypothesized that the use of the heparin-coated extracorporeal circuit is associated with less severe disturbances of the perfused boundary region than the phosphorylcholine-coated circuit.
- Healt Condition(s) or Problem(s) studiedCoronary Artery Bypass Grafting (CABG), Cardiopulmonary Bypass (CPB), Microcirculation, Cardiac surgery
- Inclusion criteria1. Adult patients undergoing CABG surgery (18-85 years);
2. Informed consent
- Exclusion criteria1. Re-operations;
2. Emergency operation;
3. Patients with diabetes mellitus;
4. Patients with a history of hematologic disorders or hepatic disease or renal replacement therapy;
5. Patients with a body mass index (BMI) above 35 kg/m2.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-nov-2013
- planned closingdate30-aug-2015
- Target number of participants44
- InterventionsThe 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 administration. 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.
- Primary outcomePerioperative changes in the perfused boundary region of the sublingual microvasculature.
- Secondary outcomeShedding of Syndecan-1, heparan sulphate and hyaluronic acid.
- TimepointsBlood will be drawn and several microcirculatory imaging parameters will be measured before surgery (T0), before (T1) and after administration of heparin (T2), after initiation of CPB (T3), after placement of the side clamp (T4), after administration of protamine (T5), after infusion of concentrated red blood cells (T6), 3 hours after the patient has arrived at the ICU (T7), and 24 hours (T8) and 72 hours (T9) following surgery.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. A.B.A. Vonk
- CONTACT for SCIENTIFIC QUERIESDr. Christa Boer
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
VU University Medical Center
- PublicationsN/A
- Brief summaryThe 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 administration. A heparin coated extracorporeal circuit might be more biocompatible with the endothelial glycocalyx, due to its comparable biochemical structure. Alternatively, a phosphorylcholine-coated extracorporeal circuit is used. The present study investigates whether the use of the heparin-coated extracorporeal circuit will contribute to the preservation of the glycocalyx during cardiac surgery, when compared to the phosphorylcholine-coated circuit.
- Main changes (audit trail)
- RECORD17-okt-2013 - 6-nov-2013


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