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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyriakos Anastasiadis, AHEPA University Hospital
ClinicalTrials.gov Identifier:
NCT01213511
First received: October 1, 2010
Last updated: November 27, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Coronary Artery Bypass
Procedure: Coronary artery bypass grafting with the use of minimal extracorporeal circulation
Procedure: Coronary artery bypass grafting under conventional extracorporeal circulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurocognitive Outcome After Coronary Artery Bypass Surgery Using Minimal Versus Conventional Extracorporeal Circulation

Resource links provided by NLM:


Further study details as provided by AHEPA University Hospital:

Primary Outcome Measures:
  • Neurocognitive outcome at 3-month follow-up [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Neurocognitive outcome at discharge [ Time Frame: 7-30 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 64
Study Start Date: January 2009
Study Completion Date: June 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213511

Locations
Greece
Department of Cardiothoracic Surgery, AHEPA University Hospital
Thessaloniki, Greece, 542 48
Sponsors and Collaborators
AHEPA University Hospital
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kyriakos Anastasiadis, Head of Cardiothoracic Department, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT01213511     History of Changes
Other Study ID Numbers: AHEPA_CTS-02
Study First Received: October 1, 2010
Last Updated: November 27, 2013
Health Authority: Greece: Ministry of Health and Welfare

Keywords provided by AHEPA University Hospital:
coronary artery disease; coronary artery bypass grafting; cardiopulmonary bypass; minimal extracorporeal circulation

ClinicalTrials.gov processed this record on October 21, 2014