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

Not Applicable

Completed

• Conditions: Acute Kidney Injury
• Interventions: Device: Minimally invasive extracorporeal circulation (MiECC); Device: Conventional extracorporeal circulation (CECC)

• Registration Number: NCT02672514
• Lead Sponsor: Herzzentrum Coswig

Brief Summary

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

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.

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2012-04
• Study Completion: 2015-06
• Study First Submitted: 2016-01-19
• Study First Submitted QC: 2016-02-01
• Study First Posted: 2016-02-03
• Results First Submitted: 2016-02-05
• Status Verified: 2017-02
• Results First Submitted QC: 2017-02-07
• Last Update Submitted: 2017-02-07
• Results First Posted: 2017-03-27
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MiECC	Minimally invasive extracorporeal circulation (MiECC)	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.
CECC	Conventional extracorporeal circulation (CECC)	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.

Primary Outcome Measures

Name	Time	Method
Acute Kidney Injury	within the first 30 days (plus or minus 3 days) after surgery