Neurocognitive Outcome After Coronary Artery Bypass Surgery Using Minimal Versus Conventional Extracorporeal Circulation
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|ClinicalTrials.gov Identifier: NCT01213511|
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : November 28, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Bypass||Procedure: Coronary artery bypass grafting with the use of minimal extracorporeal circulation Procedure: Coronary artery bypass grafting under conventional extracorporeal circulation||Not Applicable|
Despite improvements in the biocompatibility of cardiopulmonary bypass (CPB) circuits, the activation of inflammatory systemic response can result in clinically relevant organ dysfunction. Regarding the central nervous system, prolonged hypoperfusion and microembolization during conventional CPB have been related to postoperative neurologic impairment with an incidence varying from 30% to 60%. This clinical scenario covers a spectrum from a transient subtle cognitive dysfunction to a permanent stroke. Postoperative cognitive decline (POCD) is characterized as impairment in attention, cognition, recognition, orientation, memory, and learning. It may result in prolonged hospitalization, increased morbidity and mortality, while it has an adverse impact on quality of life after surgery.
Near-infrared spectroscopy (NIRS) provides a continuous and noninvasive monitoring of regional cerebral oxygen saturation (rSO2). Recent studies have shown a significant relationship between intraoperative cerebral oxygen desaturation, indicative of cerebral ischemia, and early POCD in patients undergoing elective coronary bypass grafting (CABG) with conventional extracorporeal circulation (CECC). In an attempt to reduce CPB-inherent side effects, a minimal extracorporeal circulation (MECC) system was developed and it is evaluated in clinical practice. The aim of this pilot study was to define whether there is a difference in early postoperative neurocognitive functioning between patients being operated for CABG on MECC versus CECC systems as well as whether this can be attributed to improved cerebral perfusion intraoperatively.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Neurocognitive Outcome After Coronary Artery Bypass Surgery Using Minimal Versus Conventional Extracorporeal Circulation|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||June 2012|
Active Comparator: MECC Group
Patients operated for elective coronary artery bypass grafting with the use of minimal extracorporeal circulation.
Procedure: Coronary artery bypass grafting with the use of minimal extracorporeal circulation
The MECC system (Maquet Cardiopulmonary, Hirlingen, Germany) consists of a pre-connected closed CPB circuit containing a RotaFlow centrifugal pump and a Quadrox D diffusion membrane oxygenator. A flow meter and a bubble sensor are integrated in the drive unit of the centrifugal pump. The system features a tip-to-tip heparin coating (Bioline Coating, Maquet Cardiopulmonary, Hirlingen, Germany). No arterial or venous line filters are included. Initial priming volume of the system is 500 mL, while using retrograde autologous priming (RAP) the circuit could be filled in with autologous blood, thus reducing hemodilution. Since no cardiotomy suction is used, shed blood is collected with a cell-saving device (Haemonetics Corp, Braintree, MA).
Active Comparator: CECC Group
Group of patients undergoing elective coronary bypass grafting with the use of conventional extracorporeal circulation.
Procedure: Coronary artery bypass grafting under conventional extracorporeal circulation
A standard open CPB circuit is used, consisting of uncoated PVC tubing, a hard-shell venous reservoir, a microporous membrane oxygenator (Dideco, Mirandola, Italy) and a roller pump (Stöckert S3, Munich, Germany). The circuit contains a 40 μm arterial line blood filter (Dideco, Mirandola, Italy) and it is primed with 1500 mL of a balanced crystalloid/colloid solution (1000 mL of Ringer's solution, 200 mL of mannitol 20%, and 300 mL of hydroxyethyl starch 6%). Cardiotomy as well as sump sucker are integrated to the circuit.
- Neurocognitive outcome at 3-month follow-up [ Time Frame: 3 months ]Neurocognitive outcome at 3-month follow-up after elective coronary artery bypass grafting with the use of minimal (MECC) versus conventional (CECC) extracorporeal circulation.
- Neurocognitive outcome at discharge [ Time Frame: 7-30 days ]Neurocognitive score assessed at the time of discharge after elective coronary surgery with the use of minimal (MECC) versus conventional (CECC) extracorporeal circulation.
- Episodes of intraoperative cerebral desaturation [ Time Frame: During the operation ]Number of episodes and duration of cerebral desaturation assessed with the use of near-infrared spectroscopy after elective coronary artery bypass grafting with minimal (MECC) versus conventional (CECC) extracorporeal circulation.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01213511
|Department of Cardiothoracic Surgery, AHEPA University Hospital|
|Thessaloniki, Greece, 542 48|
|Principal Investigator:||Kyriakos Anastasiadis, FETCS||Department of Cardiothoracic Surgery, AHEPA University Hospital, Thessaloniki, Greece|
|Study Chair:||Christos Papakonstantinou, Professor||Department of Cardiothoracic Surgery, AHEPA University Hospital, Thessaloniki, Greece|