Clinical trial NCT01603589: Comparison of Minimal Versus Conventional Extracorporeal Circulation in Coronary Surgery
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
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: 2012-05-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: 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 (MiECC) 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).

Detailed description: The aim of this study is to investigate whether coronary surgery with minimal Invasive Extracorporeal Circulation (MiECC) 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 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: Remote end-organ perfusion and function (brain, lungs, liver, kidneys, stomach, intestine) intraoperatively and postoperatively during hospital stay
timeFrame: 30 days
Secondary outcomes:
measure: Postoperative major adverse cardiac and cerebrovascular events (MACCE) that comprise: myocardial infarction, low cardiac output syndrome, stroke, renal failure.
timeFrame: 30 days
measure: Duration of mechanical ventilation
timeFrame: 30 days
measure: Length of ICU stay
timeFrame: 30 days
measure: Development of new postoperative atrial fibrillation.
timeFrame: 30 days
measure: Neurocognitive function
timeFrame: 6 months postoperatively
measure: Health-related quality of life
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Cardiothoracic Department, AHEPA University Hospital
Study officials:
affiliation: Cardiothoracic Department, AHEPA University Hospital, Thessaloniki, Greece
name: Kyriakos Anastasiadis, MD, PhD, FETCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anastasiadis K, Antonitsis P, Haidich AB, Argiriadou H, Deliopoulos A, Papakonstantinou C. Use of minimal extracorporeal circulation improves outcome after heart surgery; a systematic review and meta-analysis of randomized controlled trials. Int J Cardiol. 2013 Apr 5;164(2):158-69. doi: 10.1016/j.ijcard.2012.01.020. Epub 2012 Feb 8.
citation: Anastasiadis K, Asteriou C, Deliopoulos A, Argiriadou H, Karapanagiotidis G, Antonitsis P, Grosomanidis V, Misias G, Papakonstantinou C. Haematological effects of minimized compared to conventional extracorporeal circulation after coronary revascularization procedures. Perfusion. 2010 Jul;25(4):197-203. doi: 10.1177/0267659110373840. Epub 2010 Jun 1.