Cardiothoracic Department, AHEPA University Hospital
Thessaloniki, 54636, Greece
NCT Number: NCT05479188
The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation.
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Thessaloniki, 54636, Greece
Background: Cardiac surgery is performed with the use of extracorporeal circulation which triggers a systemic inflammatory response leading to end-organ dysfunction. Contemporary minimal invasive extracorporeal circulation represents an evolution of the conventional extracorporeal circulation that reduces systemic inflammatory response and improves clinical outcome in large studies. A potential explanation includes preservation of tissue microcirculation with minimal invasive extracorporeal circulation as the underlying pathophysiologic mechanism.
Aim: The aim of the present study is to detect differences in tissue microcirculation during cardiopulmonary bypass with minimal (study group) versus conventional (control group) in patients undergoing open heart surgery.
Study type: This is a randomized comparative study. Patients: The study group consists of sixty patients scheduled for elective open-heart surgery (coronary artery bypass grafting, aortic valve replacement of combined procedure) at the Cardiothoracic Department School of Medicine Aristotle University of Thessaloniki.
Intervention: Patients included in the study will be randomly assigned in two groups with a computer-generated algorithm. Study group will undergo cardiac surgery with minimal invasive extracorporeal circulation while control group will be operated with the use of conventional extracorporeal circulation.
Protocol: In both groups tissue microcirculation will be assessed with the use of a specifically designed second generation hand-held video monitoring device which uses sidestream dark field (SDF) imaging placed at the sublingual mucosa. Microcirculatory assessments will be performed at the following time-points: before induction of anesthesia (baseline - T0), after induction of general anesthesia (T1), after initiation of cardiopulmonary bypass (T2) and immediately after weaning cardiopulmonary bypass (T3).
Outcomes: The composite primary outcome of the study consists of obtained differences in the main microcirculatory quantitative variables (Proportion of Perfused Vessels, Microvascular Flow Index, Total Vascular Density, Perfused Vessel Density) during defined time points. Secondary outcomes consist of differences in postoperative 30-days morbidity and mortality.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Evaluation of microcirculation with sublingual microscopy.
Time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Proportion of perfused vessels (PPV) assessed with sublingual microscopy.
Time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Total vascular density (TVD) assessed with sublingual microscopy.
Time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Perfused vessel density (PVD) assessed with sublingual microscopy.
Time frame: During surgery, from induction of anesthesia to weaning of extracorporeal circulation
Microvascular Flow Index (MFI) assessed with sublingual microscopy
Time frame: During surgery from induction to weaning of cardiopulmonary bypass
Peak lactate levels during cardiopulmonary bypass in mmol/l
Time frame: During surgery from induction to weaning of cardiopulmonary bypass
Mean arterial pressure during cardiopulmonary bypass
Time frame: From surgery to 30 days postoperatively
Incidence of death from any cause
Time frame: From surgery to 30 days postoperatively
Incidence of perioperative myocardial infarction
Time frame: From surgery to 30 days postoperatively
Incidence of patients that experience a postperative stroke verified with CT brain scan
Time frame: From surgery to 30 days postoperatively
Incidence of patients who require postoperative revascularization
Time frame: From surgery to 30 days postoperatively
Incidence of patients that experience postoperative acute kidney injury according too AKIN criteria
Time frame: From surgery to 30 days postoperatively
Incidence of patients that required re-intubation
Time frame: From surgery to 30 days postoperatively
Incidence of patients that required a re-operation
Time frame: From ICU admission to 12 hours postoperatively
Volume of postoperative bleeding (ml)
Time frame: Postoperatively up to 30 days
Incidence of any blood product transfusion
Time frame: Perioperatively, up to 4 weeks after surgery
Total length of ICU stay in hours
Time frame: Perioperatively, from the day of operation up to 4 weeks after surgery
Length of hospital stay in days
Aristotle University Of Thessaloniki
Other
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