Does MiECC Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?

Study Overview
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Brief Summary
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The aim of this study was to prospectively evaluate MECC compared with conventional extracorporeal circulation of diabetic patients undergoing elective coronary revascularization procedures. The investigators focused on the effects of extracorporeal circulation especially the renal function between both groups.

Detailed Description
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Cardiopulmonary bypass (CPB) is known having a negative influence referring to systemic inflammatory reaction after cardiac surgery which can cause acute kidney injury (AKI). Miniaturized extracorporeal circulation (MECC) attempts to reduce the adverse effects of conventional extracorporeal circulation bypass. Finally, AKI after CPB is a significant clinical problem that increasingly complicates the course of hospitalization and clinical outcome.

Official Title
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Does Minimal Extracorporeal Circulation Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Device: Minimally invasive extracorporeal circulation (MiECC)
* Device: Conventional extracorporeal circulation (CECC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diabetes mellitus type 2 isolated elective coronary revascularization Exclusion Criteria: urgent or emergent Status Re-Operation preexisting reanimation preexisting renal transplantation chronic kidney insufficiency (GFR < 30 ml/min) renal cell carcinoma renal artery Stenosis heart valve disease (middle- and high-grade) endocarditis infections (HIV, Tbc and all types of Hepatitis) hepatic cirrhosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MiECC<br>Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility. CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation. | Device: Minimally invasive extracorporeal circulation (MiECC)<br>* Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.<br>|
| Active Comparator: CECC<br>Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter. CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg. | Device: Conventional extracorporeal circulation (CECC)<br>* Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury |  | within the first 30 days (plus or minus 3 days) after surgery |