|- candidate number||9759|
|- NTR Number||NTR2940|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-jun-2011|
|- Secondary IDs||ANES2010/070 VUMC Department of anesthesiology|
|- Public Title||Pulsatile II study.|
|- Scientific Title||Preservation of microcirculatory perfusion after pulsatile cardiopulmonary bypass: The role of prothrombogenic processes and the endothelium.|
|- ACRONYM||Pulsatile II|
|- hypothesis||Pulsatile flow during cardiopulmonary bypass (CPB) results in preservation of microcirculatory function in the early postoperative period as compared to non-pulsatile CPB.|
|- Healt Condition(s) or Problem(s) studied||Coronary Artery Bypass Grafting (CABG), Pulsatile cardiopulmonary bypass, Microcirculatory perfusion, Endothelial function, Platelet aggregation, Fibrinolysis|
|- 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).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||20-jun-2011|
|- planned closingdate||20-jun-2012|
|- Target number of participants||48|
|- Interventions||Pulsatile cardiopulmonary bypass vs. non-pulsatile cardiopulmonary bypass.|
|- 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.
|- Timepoints||Measurements take place during the day of the operation and end within 4 hours after the operation. |
|- Trial web site||www.vumc.nl/afdelingen/anesthesiologie|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. Christa Boer|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Christa Boer|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|European Association for Cardiothoracic Anesthesiologists, Institute for Cardiovascular Research|
|- Brief 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.
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.
Single-center prospective, randomized study in the VUmc.
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.
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.
|- Main changes (audit trail)|
|- RECORD||16-jun-2011 - 7-jan-2016|