Neurocognitive Outcome After Coronary Artery Bypass Surgery Using Minimal Versus Conventional Extracorporeal Circulation

Not Applicable

Completed

• Conditions: Coronary Artery Bypass
• Interventions: Procedure: Coronary artery bypass grafting with the use of minimal extracorporeal circulation; Procedure: Coronary artery bypass grafting under conventional extracorporeal circulation

• Registration Number: NCT01213511
• Lead Sponsor: AHEPA University Hospital

Brief Summary

The aim of this study is to assess the effect of minimal (MECC) versus conventional (CECC) extracorporeal circulation on neurocognitive function after elective coronary bypass grafting (CABG) as well as whether this can be attributed to improved cerebral perfusion intraoperatively.

Detailed Description

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-01
• Study First Posted: 2010-10-04
• Primary Completion: 2011-01
• Study Completion: 2012-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-27
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• All patients scheduled for elective coronary artery bypass grafting

Exclusion Criteria

• history of psychiatric disorder
• inability to undergo neuropsychological assessment
• history of transient ischemic attack or stroke
• carotid artery stenosis > 60% assessed by duplex ultrasonography

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MECC Group	Coronary artery bypass grafting with the use of minimal extracorporeal circulation	Patients operated for elective coronary artery bypass grafting with the use of minimal extracorporeal circulation.
CECC Group	Coronary artery bypass grafting under conventional extracorporeal circulation	Group of patients undergoing elective coronary bypass grafting with the use of conventional extracorporeal circulation.

Primary Outcome Measures

Name	Time	Method
Neurocognitive outcome at 3-month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Neurocognitive outcome at discharge	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	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.

Trial Locations

Locations (1)

Department of Cardiothoracic Surgery, AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece