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

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Minimally invasive extracorporeal circulation (MiECC)
Conventional extracorporeal circulation (CECC)
Sponsored by
Herzzentrum Coswig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    MiECC

    CECC

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Acute Kidney Injury

    Secondary Outcome Measures

    Full Information

    First Posted
    January 19, 2016
    Last Updated
    February 7, 2017
    Sponsor
    Herzzentrum Coswig
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02672514
    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?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    April 2012 (Actual)
    Study Completion Date
    June 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Herzzentrum Coswig

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Kidney Injury

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    104 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MiECC
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    CECC
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Device
    Intervention Name(s)
    Minimally invasive extracorporeal circulation (MiECC)
    Intervention Description
    Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.
    Intervention Type
    Device
    Intervention Name(s)
    Conventional extracorporeal circulation (CECC)
    Intervention Description
    Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.
    Primary Outcome Measure Information:
    Title
    Acute Kidney Injury
    Time Frame
    within the first 30 days (plus or minus 3 days) after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

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

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