Comparison of Minimal Versus Conventional Extracorporeal Circulation in Coronary Surgery

Not Applicable

Completed

• Conditions: Coronary Artery Bypass
• Interventions: Procedure: Coronary artery bypass grafting under conventional extracorporeal circulation; Procedure: Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation

• Registration Number: NCT01603589
• Lead Sponsor: AHEPA University Hospital

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2012-05-21
• Study First Submitted QC: 2012-05-21
• Study First Posted: 2012-05-22
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CECC group	Coronary artery bypass grafting under conventional extracorporeal circulation	Patients operated for elective coronary artery bypass grafting under conventional extracorporeal circulation (CECC).
MiECC group	Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation	Patients operated for elective coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation (MiECC).

Primary Outcome Measures

Name	Time	Method
Remote end-organ perfusion and function (brain, lungs, liver, kidneys, stomach, intestine) intraoperatively and postoperatively during hospital stay	30 days	Remote end-organ perfusion and function at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.

Secondary Outcome Measures

Name	Time	Method
Development of new postoperative atrial fibrillation.	30 days	Development of new postoperative atrial fibrillation at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
Health-related quality of life	6 months postoperatively	Change in quality of life assessed with SF-36 questionnaire after coronary artery bypass grafting with minimal versus conventional extracorporeal circulation.
Length of ICU stay	30 days	Length of ICU stay at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.
Neurocognitive function	6 months postoperatively	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.
Postoperative major adverse cardiac and cerebrovascular events (MACCE) that comprise: myocardial infarction, low cardiac output syndrome, stroke, renal failure.	30 days	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 (MiECC) versus conventional (CECC) extracorporeal circulation.
Duration of mechanical ventilation	30 days	Duration of mechanical ventilation at 30 days follow-up after elective coronary artery bypass grafting with the use of minimal (MiECC) versus conventional (CECC) extracorporeal circulation.

Trial Locations

Locations (1)

Cardiothoracic Department, AHEPA University Hospital; 🇬🇷 Thessaloniki, Greece