The aim of the present study is to investigate the protective effect of minimal invasive versus the conventional extracorporeal circulation on tissue homeostasis as evidenced by the preservation of tissue metabolism and cerebral perfusion.
The aim of the present study is to investigate the protective effect of minimal invasive versus the conventional extracorporeal circulation on tissue homeostasis as evidenced by the preservation of tissue metabolism and cerebral perfusion. Seventy patients undergoing coronary artery bypass grafting, aortic valve replacement or both procedures will be included in the study. Patients will be randomized in two groups: patients operated with the contemporary minimal invasive extracorporeal circulation (study group) versus patients operated with conventional extracorporeal circulation (control group). All patients will be operated according to the same anesthetic and perfusion protocol. During extracorporeal circulation, the following parameters will be recorded: * real-time tissue metabolism as indicated by oxygen delivery (DO2), oxygen consumption (VO2), oxygen extraction ratio (O2ER), CO2 consumption (VCO2), arterial and mixed venous saturation (SvO2) * blood lactate levels at defined intervals * real time cerebral oximetry (rSO2) using near-infrared spectroscopy (NIRS) The protective effect of minimal invasive extracorporeal circulation will be evidenced with comparative analysis of metabolic parameters between the two study groups. Real-time tissue metabolic parameters will be further associated with clinical data collected during hospital stay including postoperative morbidity and mortality, major adverse cardiac events, acute renal failure, re-intubation, need for prolonged mechanical ventilation (\> 48 hours), re-operation, postoperative bleeding, need for blood product transfusion, ICU and total hospital stay.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
Real-time tissue metabolism as indicated by oxygen delivery (DO2), oxygen consumption (VO2), oxygen extraction ratio (O2ER), CO2 consumption (VCO2), arterial and mixed venous saturation (SvO2)
Cardiothoracic Department, Artistotle University of Thessaloniki School of Medicine
Thessaloniki, Greece
Tissue hypoperfusion severity
Area under the curve (AUC) where tissue oxygen delivery indexed (DO2i) remains below the critical value of 280 ml/min/m2.
Time frame: During surgery, from initiation of cardiopulmonary bypass to weaning of cardiopulmonary bypass
Perfusion ratio derangement
Incidence of patients that experience perfusion ratio (DO2i/VCO2i) \< 5 during extracorporeal circulation.
Time frame: During surgery from initiation of extracorporeal circulation to weaning of extracorporeal circulation.
Cerebral hypoperfusion
Incidence of patients that experience a reduction in cerebral near-infrared spectroscopy exceeding -20% from baseline during extracorporeal circulation.
Time frame: During surgery, from initiation to weaning of extracorporeal circulation
Overall mortality
Death from any cause
Time frame: From surgery to 30 days postoperatively
Major adverse cardiac and cerebrovascular events
Composite incidense od postoperative stroke, myocardial infarction and need fr revascularization.
Time frame: From surgery to 30 days postoperatively
Renal failure
Incidence of postoperative renal failure
Time frame: From surgery to 30 days postoperatively
Re-intubation
Incidence of re-intubation
Time frame: From surgery to 30 days postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
70
Re-operation
Incidence of re-operation
Time frame: From surgery to 30 days postoperatively
Postoperative bleeding
Volume of postoperative blood loss
Time frame: From surgery to 12 hours postoperatively
Transfusion
Any blood product transfused
Time frame: Perioperatively
ICU stay
Length of ICU stay
Time frame: From day of surgery to discharge from ICU, assessed up to 4 weeks postoperatively.
Hospital stay
Length of hospital stay
Time frame: From day of surgery to discharge from hospital, assessed up to 4 weeks postoperatively.