Aortic Valve Surgery, Cardiac Surgery, Coronary Artery Bypass Graft (CABG)
Conditions
Keywords
cardiopulmonary bypass, minimal invasive extracorporeal circulation, extracorporeal circulation, tissue oximetry, near-infrared spectroscopy
Brief summary
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.
Detailed description
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.
Interventions
DEVICEReal-time tissue oximetry monitoring
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)
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All eligible patients will be randomized with computer-generated algorithm to receive cardiac surgery with minimal invasive versus conventional extracorporeal circulation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing undergoing open heart surgery with accepted indications under extracorporeal circulation
Exclusion criteria
* need for emergency surgery * surgery on the thoracic aorta * severe co-morbities causing anemia, immunosuppression etc. * immunocompromised patients * inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue hypoperfusion severity | During surgery, from initiation of cardiopulmonary bypass to weaning of cardiopulmonary bypass | Area under the curve (AUC) where tissue oxygen delivery indexed (DO2i) remains below the critical value of 280 ml/min/m2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perfusion ratio derangement | During surgery from initiation of extracorporeal circulation to weaning of extracorporeal circulation. | Incidence of patients that experience perfusion ratio (DO2i/VCO2i) \< 5 during extracorporeal circulation. |
| Cerebral hypoperfusion | During surgery, from initiation to weaning of extracorporeal circulation | Incidence of patients that experience a reduction in cerebral near-infrared spectroscopy exceeding -20% from baseline during extracorporeal circulation. |
| Overall mortality | From surgery to 30 days postoperatively | Death from any cause |
| Major adverse cardiac and cerebrovascular events | From surgery to 30 days postoperatively | Composite incidense od postoperative stroke, myocardial infarction and need fr revascularization. |
| Renal failure | From surgery to 30 days postoperatively | Incidence of postoperative renal failure |
| Re-intubation | From surgery to 30 days postoperatively | Incidence of re-intubation |
| Re-operation | From surgery to 30 days postoperatively | Incidence of re-operation |
| Postoperative bleeding | From surgery to 12 hours postoperatively | Volume of postoperative blood loss |
| Transfusion | Perioperatively | Any blood product transfused |
| ICU stay | From day of surgery to discharge from ICU, assessed up to 4 weeks postoperatively. | Length of ICU stay |
| Hospital stay | From day of surgery to discharge from hospital, assessed up to 4 weeks postoperatively. | Length of hospital stay |
Countries
Greece
Contacts
STUDY_CHAIRKyriakos Anastasiadis, MD, PhD, FETCS
Aristotle University Of Thessaloniki
Outcome results
None listed