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

• ClinicalTrials.gov Identifier: NCT02672514
• Recruitment Status: Completed
• First Posted: February 3, 2016
• Results First Posted: March 27, 2017
• Last Update Posted: March 27, 2017
• Sponsor: Herzzentrum Coswig
• Information provided by (Responsible Party): PD Dr. Hausmann, Herzzentrum Coswig

Tracking Information

• First Submitted Date: January 19, 2016
• First Posted Date: February 3, 2016
• Results First Submitted Date: February 5, 2016
• Results First Posted Date: March 27, 2017
• Last Update Posted Date: March 27, 2017
• Study Start Date: February 2010
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 1, 2016): Acute Kidney Injury [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Does MiECC Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?
• Official Title: Does Minimal Extracorporeal Circulation Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Acute Kidney Injury

Intervention

• Device: Minimally invasive extracorporeal circulation (MiECC)
  Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.
• Device: Conventional extracorporeal circulation (CECC)
  Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.

Study Arms

• Active Comparator: 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.

  Intervention: Device: Minimally invasive extracorporeal circulation (MiECC)
• Active Comparator: 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.

  Intervention: Device: Conventional extracorporeal circulation (CECC)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 1, 2016): 104
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02672514
• Other Study ID Numbers: Rölig Studie
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: PD Dr. Hausmann, Herzzentrum Coswig
• Study Sponsor: Herzzentrum Coswig
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Herzzentrum Coswig
• Verification Date: February 2017