Comparison of Minimal Versus Conventional Extracorporeal Circulation in Coronary Surgery

This study is currently recruiting participants.
Verified November 2013 by AHEPA University Hospital
Sponsor:
Information provided by (Responsible Party):
Kyriakos Anastasiadis, AHEPA University Hospital
ClinicalTrials.gov Identifier:
NCT01603589
First received: May 21, 2012
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 perfusion characteristics and remote end-organ protection (lungs, brain, kidneys, liver, stomach, intestine), after elective coronary bypass grafting (CABG).


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: Research on Remote End-organ Protection, Clinical Outcome and Quality of Life With Implementation of the Novel Minimal Extracorporeal Circulation Circuit in Open Heart Surgery

Resource links provided by NLM:


Further study details as provided by AHEPA University Hospital:

Primary Outcome Measures:
  • Remote end-organ perfusion and function (brain, lungs, liver, kidneys, stomach, intestine) intraoperatively and postoperatively during hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Remote end-organ perfusion and function at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MECC) versus conventional (CECC) extracorporeal circulation.


Secondary Outcome Measures:
  • Postoperative major adverse cardiac and cerebrovascular events (MACCE) that comprise: myocardial infarction, low cardiac output syndrome, stroke, renal failure. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Postoperative major adverse cardiac and cerebrovascular events (MACCE) that comprise: myocardial infarction, low cardiac output syndrome, stroke, renal failure at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MECC) versus conventional (CECC) extracorporeal circulation.

  • Duration of mechanical ventilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Duration of mechanical ventilation at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MECC) versus conventional (CECC) extracorporeal circulation.

  • Length of ICU stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Length of ICU stay at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MECC) versus conventional (CECC) extracorporeal circulation.

  • Development of new postoperative atrial fibrillation. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Development of new postoperative atrial fibrillation at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MECC) versus conventional (CECC) extracorporeal circulation.

  • Neurocognitive function [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
    Neurocognitive evaluation with a battery of specialized tests performed by a dedicated and experienced team in clinical psychology. Evaluation will be performed at specific time intervals: preoperatively, at 1-, 3- and 6-month follow-up.

  • Health-related quality of life [ Time Frame: 6 months postoperatively ] [ Designated as safety issue: No ]
    Change in quality of life assessed with SF-36 questionnaire after coronary artery bypass grafting with minimal versus conventional extracorporeal circulation.


Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (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
Patients operated for elective coronary artery bypass grafting under 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:

The aim of this study is to investigate whether coronary surgery with MECC offers advantage over conventional CPB (CECC). In order to draw an evidence-based conclusion, the investigators aim to evaluate perfusion characteristics during coronary surgery with MECC and associated remote end-organ function. Improved end-organ protection translates into improved clinical outcome which greatly affects quality of life. This is the first study in the literature adequately powered to analyse organ pathophysiology during surgery with MECC and at the same time correlating common clinical variables with a detailed quality of life evaluation. Superiority of MECC could provide firm evidence towards widespread use of MECC in coronary surgery as standard of care.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603589

Contacts
Contact: Kyriakos Anastasiadis, DSc, FETCS +30 2310994845 anastasiadisk@hotmail.com
Contact: Polychronis N Antonitsis, DSc +30 2310993931 antonits@otenet.gr

Locations
Greece
Department of Cardiothoracic Surgery, AHEPA University Hospital Recruiting
Thessaloniki, Greece
Contact: Polychronis Antonitsis, DSc    +30 2310994871    antonits@otenet.gr   
Principal Investigator: Kyriakos Anastasiadis, PhD, FETCS         
Sub-Investigator: Polychronis N Antonitsis, PhD         
Sub-Investigator: Christos Asteriou, MSc         
Sponsors and Collaborators
AHEPA University Hospital
Investigators
Principal Investigator: Kyriakos Anastasiadis, FETCS Department of Cardiothoracic Surgery, AHEPA University Hospital, Thessaloniki, Greece
  More Information

Additional Information:
Publications:
Responsible Party: Kyriakos Anastasiadis, Professor, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT01603589     History of Changes
Other Study ID Numbers: AHEPA_CTS_04
Study First Received: May 21, 2012
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 April 16, 2014