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

Coronary Artery Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01213511
• Other study ID #: AHEPA_CTS-02
• Status: Completed
• Phase: N/A
• First received: October 1, 2010
• Last updated: November 27, 2013
• Start date: January 2009
• Est. completion date: June 2012

Study information

• Verified date: November 2013
• Source: AHEPA University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass

Intervention

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).
• 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.

Locations

Country	Name	City	State
Greece	Department of Cardiothoracic Surgery, AHEPA University Hospital	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
AHEPA University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (2)

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. Epub 2006 Jan 18. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive outcome at 3-month follow-up	Neurocognitive outcome at 3-month follow-up after elective coronary artery bypass grafting with the use of minimal (MECC) versus conventional (CECC) extracorporeal circulation.	3 months	No
Secondary	Neurocognitive outcome at discharge	Neurocognitive score assessed at the time of discharge after elective coronary surgery with the use of minimal (MECC) versus conventional (CECC) extracorporeal circulation.	7-30 days	No
Secondary	Episodes of intraoperative cerebral desaturation	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.	During the operation	No

External Links

•   CardioThoracic Surgery Network