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

NCT ID: NCT02672514

Last Updated: 2017-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2015-06-30

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.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Minimally invasive extracorporeal circulation (MiECC)

Intervention Type: DEVICE

Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.

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.

Group Type: ACTIVE_COMPARATOR

Conventional extracorporeal circulation (CECC)

Intervention Type: DEVICE

Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.

Interventions

Minimally invasive extracorporeal circulation (MiECC)

Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.

Intervention Type: DEVICE

Conventional extracorporeal circulation (CECC)

Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Herzzentrum Coswig

OTHER

Sponsor Role: lead

Responsible Party

PD Dr. Hausmann

chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Rölig Studie

Identifier Type: -

Identifier Source: org_study_id