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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Kidney Injury Device: Minimally invasive extracorporeal circulation (MiECC) Device: Conventional extracorporeal circulation (CECC) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Does Minimal Extracorporeal Circulation Improve Outcome in Diabetic Patients Undergoing Elective Coronary Bypass Grafting?
Study Start Date : February 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : June 2015

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Arms and Interventions
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Arm Intervention/treatment
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.

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

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


Outcome Measures
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Primary Outcome Measures :
  1. Acute Kidney Injury [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: PD Dr. Hausmann, chief physician, Herzzentrum Coswig
ClinicalTrials.gov Identifier: NCT02672514    
Other Study ID Numbers: Rölig Studie
First Posted: February 3, 2016    Key Record Dates
Results First Posted: March 27, 2017
Last Update Posted: March 27, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases