|- candidate number||5447|
|- NTR Number||NTR1723|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-mrt-2009|
|- Secondary IDs||NL27129 ABR |
|- Public Title||Evaluation of cerebral circulation and metabolic properties in patients undergoing normothermic cardiopulmonary bypass with acute normovolemic hemodilution.|
|- Scientific Title||Evaluation of cerebral circulation and metabolic properties in patients undergoing normothermic cardiopulmonary bypass with acute normovolemic hemodilution.|
|- ACRONYM||Hemodilution and cerebral autoregulation.|
|- hypothesis||Acute normovolemic hemodilution during coronary artery bypass surgery involving normothermic cardiopulmonary bypass (CPB) leads to dysfunction of cerebral autoregulation and therefore contributes to neurological morbidity after cardiac surgery.|
|- Healt Condition(s) or Problem(s) studied||Cardiopulmonary Bypass (CPB)|
|- Inclusion criteria||1. Elective adult candidates for CABG surgery using CPB;|
2. Male gender;
3. Age: 50 -70 years old;
4. Presence of a trans-temporal bone window;
5. Informed written consent obtained by the patient.
|- Exclusion criteria||1. Patients suffering from neurological disorders (e.g. cerebrovascular accident);|
2. Patients suffering from renal diseases (e.g. renal failure, defined as laboratory tests indicating values of 2 or more times the normal values [urea >= 50 U/L, kreatinine >= 170 micromol/L]);
3. Patients suffering from liver diseases, defined as laboratory tests indicating values of 2 or more times the normal values (ASAT >= 50 U/L, ALAT >= 60 U/L, LD >= 600 U/L and gamma-GT >= 90 U/L);
4. Patients suffering from severe pulmonary disorders (e.g. chronic obstructive pulmonary disease, emphysema);
5. Insulin / non insulin dependent diabetics;
6. Hypothermia during CPB;
7. Severe atherosclerosis of the carotid or the middle cerebral artery;
8. Participation in an investigational drug trial within the preceding 30 days.
|- mec approval received||no|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mei-2009|
|- planned closingdate||1-okt-2009|
|- Target number of participants||40|
|- Primary outcome||To evaluate the effects of normovolemic hemodilution levels during CPB on the dynamic cerebral autoregulation and cerebrovascular reactivity.|
|- Secondary outcome||1. To evaluate the dynamic cerebral autoregulation with transcranial Doppler velocity and near infrared spectroscopy at different PaCO2 levels during normothermic CPB;|
2. To evaluate the relation between PaCO2 values and the amount of micro emboli signals during CPB.
|- Timepoints||Only peroperative measurement of standard recorded data.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MD, PhD Werner Mess|
|- CONTACT for SCIENTIFIC QUERIES||MD, PhD Werner Mess|
|- Sponsor/Initiator ||University Hospital Maastricht (AZM), Department of Cardiothoracic Surgery|
(Source(s) of Monetary or Material Support)
|University Hospital Maastricht (AZM), Department of Cardiothoracic Surgery|
|- Brief summary||Rationale: |
The objective of this clinical study is to endorse the hypothesis that acute normovolemic hemodilution during coronary artery bypass surgery involving normothermic cardiopulmonary bypass (CPB) may lead to dysfunction of cerebral autoregulation and therefore contribute to neurological morbidity after cardiac surgery.
Primary objective is to evaluate the effects of normovolemic hemodilution levels during CPB on the dynamic cerebral autoregulation (dCA) and cerebrovascular reactivity (CVR).
Secondary objective is to evaluate dCA with transcranial Doppler (TCD) velocity and near infrared spectroscopy (NIRS) at different arterial carbon dioxide tension (PaCO2) levels during normothermic CPB.
Third objective is to evaluate the relation between PaCO2 values and the amount of micro embolic signals (MES) during CPB.
A prospective randomized observational clinical trial.
Forty adult male patients scheduled for elective coronary artery bypass grafting (CABG) surgery will be randomly divided in two groups. CPB will be conducted using either a standard minimized extracorporeal circuit (MEC) or a conventional extracorporeal circuit (CEC).
Intervention (if applicable):
Main study parameters/endpoints:
Primary endpoint: Difference of dCA and CVR measured by TCD and NIRS.
Secondary endpoints: PaCO2 levels and amount of MES during CPB.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No additional risk than for those patients undergoing CABG surgery that are not involve in the study. Differences in the two groups of extracorporeal systems regarding primary and secondary objective are to be investigated. Both devices have been successfully used clinically for years, and have been established as standard devices to take over heart and lung function during heart surgery.
Optimization of the CPB system and conduct in order to reduce CPB-related neurological morbidity after cardiac surgery.
|- Main changes (audit trail)|
|- RECORD||12-mrt-2009 - 14-sep-2009|