Clinical trial NCT01213511: Neurocognitive Outcome After Coronary Artery Bypass Surgery Using Minimal Versus Conventional Extracorporeal Circulation
Official title: Neurocognitive Outcome After Coronary Artery Bypass Surgery Using Minimal Versus Conventional Extracorporeal Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass
Keywords: coronary artery disease; coronary artery bypass grafting; cardiopulmonary bypass; minimal extracorporeal circulation
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
First posted: 2010-10-04
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neurocognitive outcome at 3-month follow-up
timeFrame: 3 months
Secondary outcomes:
measure: Neurocognitive outcome at discharge
timeFrame: 7-30 days
measure: Episodes of intraoperative cerebral desaturation
timeFrame: During the operation
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Department of Cardiothoracic Surgery, AHEPA University Hospital
Study officials:
affiliation: Department of Cardiothoracic Surgery, AHEPA University Hospital, Thessaloniki, Greece
name: Kyriakos Anastasiadis, FETCS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Cardiothoracic Surgery, AHEPA University Hospital, Thessaloniki, Greece
name: Christos Papakonstantinou, Professor
role: STUDY_CHAIR
References:
citation: Murkin JM, Newman SP, Stump DA, Blumenthal JA. Statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery. Ann Thorac Surg. 1995 May;59(5):1289-95. doi: 10.1016/0003-4975(95)00106-u. No abstract available.
citation: Liebold A, Khosravi A, Westphal B, Skrabal C, Choi YH, Stamm C, Kaminski A, Alms A, Birken T, Zurakowski D, Steinhoff G. Effect of closed minimized cardiopulmonary bypass on cerebral tissue oxygenation and microembolization. J Thorac Cardiovasc Surg. 2006 Feb;131(2):268-76. doi: 10.1016/j.jtcvs.2005.09.023. Epub 2006 Jan 18.
citation: Anastasiadis K, Argiriadou H, Kosmidis MH, Megari K, Antonitsis P, Thomaidou E, Aretouli E, Papakonstantinou C. Neurocognitive outcome after coronary artery bypass surgery using minimal versus conventional extracorporeal circulation: a randomised controlled pilot study. Heart. 2011 Jul;97(13):1082-8. doi: 10.1136/hrt.2010.218610. Epub 2011 Feb 28.