Coronary Artery Disease, Aortic Valve Stenosis, Mitral Disease
Conditions
Keywords
extracorporeal circulation, Minimal Invasive Extracorporeal Circulation, cardiopulmonary bypass, cerebral oximetry, microcirculation, near-infrared spectroscopy
Brief summary
The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation.
Detailed description
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.
Interventions
DEVICESublingual microscopy
Evaluation of microcirculation with sublingual microscopy.
Sponsors
Aristotle University Of Thessaloniki
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)
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 85 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing undergoing open heart surgery with accepted indications under extracorporeal circulation
Exclusion criteria
* patients undergoing emergency surgery * patients in preoperative cardiogenic shock with evidence of tissue malperfusion * patients with severe peripheral vascular disease * patients unable to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of perfused vessels assessed with sublingual microscopy | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | Proportion of perfused vessels (PPV) assessed with sublingual microscopy. |
| Total vascular density assessed with sublingual microscopy | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | Total vascular density (TVD) assessed with sublingual microscopy. |
| Perfused vessel density assessed with sublingual microscopy | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | Perfused vessel density (PVD) assessed with sublingual microscopy. |
| Microvascular Flow Index (MFI) | During surgery, from induction of anesthesia to weaning of extracorporeal circulation | Microvascular Flow Index (MFI) assessed with sublingual microscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Peak lactate levels | During surgery from induction to weaning of cardiopulmonary bypass | Peak lactate levels during cardiopulmonary bypass in mmol/l |
| Mean arterial pressure | During surgery from induction to weaning of cardiopulmonary bypass | Mean arterial pressure during cardiopulmonary bypass |
| Overall mortality rate | From surgery to 30 days postoperatively | Incidence of death from any cause |
| Rate of preoperative myocardial infarction | From surgery to 30 days postoperatively | Incidence of perioperative myocardial infarction |
| Rate of postoperative stroke | From surgery to 30 days postoperatively | Incidence of patients that experience a postperative stroke verified with CT brain scan |
| Rate of postoperative revascularization | From surgery to 30 days postoperatively | Incidence of patients who require postoperative revascularization |
| Rate of postoperative renal failure | From surgery to 30 days postoperatively | Incidence of patients that experience postoperative acute kidney injury according too AKIN criteria |
| Rate of re-intubation | From surgery to 30 days postoperatively | Incidence of patients that required re-intubation |
| Rate of re-operation | From surgery to 30 days postoperatively | Incidence of patients that required a re-operation |
| Volume of postoperative bleeding | From ICU admission to 12 hours postoperatively | Volume of postoperative bleeding (ml) |
| Rate of blood product transfusion | Postoperatively up to 30 days | Incidence of any blood product transfusion |
| Length of ICU stay | Perioperatively, up to 4 weeks after surgery | Total length of ICU stay in hours |
| Length of hospital stay | Perioperatively, from the day of operation up to 4 weeks after surgery | Length of hospital stay in days |
Countries
Greece
Contacts
STUDY_DIRECTORKyriakos Anastasiadis, Prof.
Aristotle University Of Thessaloniki
PRINCIPAL_INVESTIGATORHelena Argiriadou, Assoc. Prof.
Aristotle University Of Thessaloniki
Outcome results
None listed