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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AHEPA University Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Remote end-organ perfusion and function (brain, lungs, liver, kidneys, stomach, intestine) intraoperatively and postoperatively during hospital stay
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MiECC group
Patients operated for elective coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation (MiECC).
Intervention: Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation (Procedure)
CECC group
Patients operated for elective coronary artery bypass grafting under conventional extracorporeal circulation (CECC).
Intervention: Coronary artery bypass grafting under conventional extracorporeal circulation (Procedure)
Outcomes
Primary Outcomes
Remote end-organ perfusion and function (brain, lungs, liver, kidneys, stomach, intestine) intraoperatively and postoperatively during hospital stay
Time Frame: 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 Outcomes
- Duration of mechanical ventilation(30 days)
- Development of new postoperative atrial fibrillation.(30 days)
- Health-related quality of life(6 months postoperatively)
- Length of ICU stay(30 days)
- Neurocognitive function(6 months postoperatively)
- Postoperative major adverse cardiac and cerebrovascular events (MACCE) that comprise: myocardial infarction, low cardiac output syndrome, stroke, renal failure.(30 days)
Investigators
Kyriakos Anastasiadis
Professor
AHEPA University Hospital