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

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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:
Information provided by (Responsible Party):
PD Dr. Hausmann, Herzzentrum Coswig

Tracking Information
First Submitted Date  ICMJE January 19, 2016
First Posted Date  ICMJE February 3, 2016
Results First Submitted Date  ICMJE February 5, 2016
Results First Posted Date  ICMJE March 27, 2017
Last Update Posted Date March 27, 2017
Study Start Date  ICMJE February 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Does MiECC Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Acute Kidney Injury
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 1, 2016)
104
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02672514
Other Study ID Numbers  ICMJE Rölig Studie
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PD Dr. Hausmann, Herzzentrum Coswig
Study Sponsor  ICMJE Herzzentrum Coswig
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Herzzentrum Coswig
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP