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The aim of the proposed study is to evaluate microcirculatory alterations in patients undergoing open heart surgery with minimal invasive versus conventional extracorporeal circulation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimal Invasive Extracorporeal Circulation (MiECC) | Active Comparator | Patients undergoing cardiac surgery with Minimal Invasive Extracorporeal Circulation. |
|
| Conventional cardiopulmonary Bypass (cCPB) | Active Comparator | Patients undergoing cardiac surgery with conventional cardiopulmonary bypass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sublingual microscopy | Device | Evaluation of microcirculation with sublingual microscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of perfused vessels assessed with sublingual microscopy | Proportion of perfused vessels (PPV) assessed with sublingual microscopy. | During surgery, from induction of anesthesia to weaning of extracorporeal circulation |
| Total vascular density assessed with sublingual microscopy | Total vascular density (TVD) assessed with sublingual microscopy. | During surgery, from induction of anesthesia to weaning of extracorporeal circulation |
| Perfused vessel density assessed with sublingual microscopy | Perfused vessel density (PVD) assessed with sublingual microscopy. | During surgery, from induction of anesthesia to weaning of extracorporeal circulation |
| Microvascular Flow Index (MFI) | Microvascular Flow Index (MFI) assessed with sublingual microscopy | During surgery, from induction of anesthesia to weaning of extracorporeal circulation |
| Measure | Description | Time Frame |
|---|---|---|
| Peak lactate levels | Peak lactate levels during cardiopulmonary bypass in mmol/l | During surgery from induction to weaning of cardiopulmonary bypass |
| Mean arterial pressure | Mean arterial pressure during cardiopulmonary bypass |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyriakos Anastasiadis, Prof. | Aristotle University Of Thessaloniki | Study Director |
| Helena Argiriadou, Assoc. Prof. | Aristotle University Of Thessaloniki | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiothoracic Department, AHEPA University Hospital | Thessaloniki | 54636 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28692337 | Background | Anastasiadis K, Antonitsis P, Deliopoulos A, Argiriadou H. A multidisciplinary perioperative strategy for attaining "more physiologic" cardiac surgery. Perfusion. 2017 Sep;32(6):446-453. doi: 10.1177/0267659117700488. Epub 2017 Mar 10. | |
| 22700685 | Background | Yuruk K, Bezemer R, Euser M, Milstein DM, de Geus HH, Scholten EW, de Mol BA, Ince C. The effects of conventional extracorporeal circulation versus miniaturized extracorporeal circulation on microcirculation during cardiopulmonary bypass-assisted coronary artery bypass graft surgery. Interact Cardiovasc Thorac Surg. 2012 Sep;15(3):364-70. doi: 10.1093/icvts/ivs271. Epub 2012 Jun 14. |
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All eligible patients will be randomized with computer-generated algorithm to receive cardiac surgery with minimal invasive versus conventional extracorporeal circulation.
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| During surgery from induction to weaning of cardiopulmonary bypass |
| Overall mortality rate | Incidence of death from any cause | From surgery to 30 days postoperatively |
| Rate of preoperative myocardial infarction | Incidence of perioperative myocardial infarction | From surgery to 30 days postoperatively |
| Rate of postoperative stroke | Incidence of patients that experience a postperative stroke verified with CT brain scan | From surgery to 30 days postoperatively |
| Rate of postoperative revascularization | Incidence of patients who require postoperative revascularization | From surgery to 30 days postoperatively |
| Rate of postoperative renal failure | Incidence of patients that experience postoperative acute kidney injury according too AKIN criteria | From surgery to 30 days postoperatively |
| Rate of re-intubation | Incidence of patients that required re-intubation | From surgery to 30 days postoperatively |
| Rate of re-operation | Incidence of patients that required a re-operation | From surgery to 30 days postoperatively |
| Volume of postoperative bleeding | Volume of postoperative bleeding (ml) | From ICU admission to 12 hours postoperatively |
| Rate of blood product transfusion | Incidence of any blood product transfusion | Postoperatively up to 30 days |
| Length of ICU stay | Total length of ICU stay in hours | Perioperatively, up to 4 weeks after surgery |
| Length of hospital stay | Length of hospital stay in days | Perioperatively, from the day of operation up to 4 weeks after surgery |
| 22698563 | Background | Donndorf P, Kuhn F, Vollmar B, Rosner J, Liebold A, Gierer P, Steinhoff G, Kaminski A. Comparing microvascular alterations during minimal extracorporeal circulation and conventional cardiopulmonary bypass in coronary artery bypass graft surgery: a prospective, randomized study. J Thorac Cardiovasc Surg. 2012 Sep;144(3):677-83. doi: 10.1016/j.jtcvs.2012.05.037. Epub 2012 Jun 12. |
| 24161555 | Background | Koning NJ, Vonk AB, Meesters MI, Oomens T, Verkaik M, Jansen EK, Baufreton C, Boer C. Microcirculatory perfusion is preserved during off-pump but not on-pump cardiac surgery. J Cardiothorac Vasc Anesth. 2014 Apr;28(2):336-41. doi: 10.1053/j.jvca.2013.05.026. Epub 2013 Oct 23. |
| 26658179 | Background | Kara A, Akin S, Ince C. The response of the microcirculation to cardiac surgery. Curr Opin Anaesthesiol. 2016 Feb;29(1):85-93. doi: 10.1097/ACO.0000000000000280. |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D001024 | Aortic Valve Stenosis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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