Back to resultsComputerized Tight Glycemic Control in Cardiac Surgery
Primary Purpose
Hyperglycemia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Space GlucoseControl System, B. Braun, Melsungen, Germany
Conventional therapy with a fixed insulin dosing scheme
Sponsored by
About this trial
This is an interventional treatment trial for Hyperglycemia focused on measuring Computer based glycemic control, insulin, blood glucose
Eligibility Criteria
Inclusion Criteria:
- patients over 18 scheduled for elective cardiac surgery with the use of cardiopulmonary bypass and blood cardioplegia
Exclusion Criteria:
- under 18 years of age, or if patients had a premedical history of steroid therapy
Sites / Locations
- University Medical Center Hamburg-Eppendorf
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Other
Arm Label
Group A
Group B
Group C
Arm Description
With start of the cardiopulmonary bypass, computerized algorithmic application of insulin was performed with a dedicated computerized syringe pump system (Space GlucoseControl System, B. Braun, Germany). The targeted corridor for blood glucose was determined with 80 - 150 mg/dl. During surgery, blood glucose was measured every 30 min, and on the ICU every 2 hours. TGC management was continued until ICU discharge.
Corresponding computerized algorithmic application of insulin management was used as for group A. However, only the interval of blood glucose measurement during surgery was adjusted to 15 minutes.
With start of the cardiopulmonary bypass conventional therapy with a fixed insulin dosing scheme was initiated. If blood glucose was > 150 mg/dl, manual insulin therapy was started following a fixed insulin dosing scheme. Measurements of blood glucose were performed during surgery every 30 minutes, and on the ICU every 2 hours until discharge (Routine Care).
Outcomes
Primary Outcome Measures
Time within a blood glucose corridor of 80 - 150 mg/dl
The primary endpoint was defined as the time within a given blood glucose corridor from 80 - 150 mg/dl during therapy
Secondary Outcome Measures
Hypoglycemic events
Secondary endpoints were the number of hypoglycemic events defined as blood glucose levels under 80 mg/dl
Full Information
NCT ID
NCT01886365
First Posted
June 12, 2013
Last Updated
June 24, 2013
Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
B. Braun Melsungen AG
1. Study Identification
Unique Protocol Identification Number
NCT01886365
Brief Title
Computerized Tight Glycemic Control in Cardiac Surgery
Official Title
Perioperative Glycemic Control With a Computerized Algorithm vs. Conventional Glycemic Control in Cardio-surgical Patients Undergoing Cardiopulmonary Bypass With Blood Cardioplegia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
Collaborators
B. Braun Melsungen AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The debate about tight glycemic control (TGC) in the operating room and on the intensive care unit is ongoing, especially in cardio-surgical patients treated with blood cardioplegia, due to high blood glucose levels during operations and subsequent high rates of sternal wound infections. We showed in a feasibility study that early computer based insulin therapy starting in the operating room is a safe therapy that allows to better warrant normoglycemia in patients undergoing major cardiac surgery with the use of blood cardioplegia.
Detailed Description
Patients are enrolled and randomized into 3 groups. Start of therapy is determined as the beginning of cardiopulmonary bypass. Group A: Therapy with computer-based algorithm and measurement of blood glucose every 30 min. Group B: Measurement of blood glucose every 15 min using the identical computer-based algorithm. Group C: Conventional therapy using a fixed insulin dosing scheme. End of therapy is defined as discharge from ICU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia
Keywords
Computer based glycemic control, insulin, blood glucose
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
With start of the cardiopulmonary bypass, computerized algorithmic application of insulin was performed with a dedicated computerized syringe pump system (Space GlucoseControl System, B. Braun, Germany). The targeted corridor for blood glucose was determined with 80 - 150 mg/dl. During surgery, blood glucose was measured every 30 min, and on the ICU every 2 hours. TGC management was continued until ICU discharge.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Corresponding computerized algorithmic application of insulin management was used as for group A. However, only the interval of blood glucose measurement during surgery was adjusted to 15 minutes.
Arm Title
Group C
Arm Type
Other
Arm Description
With start of the cardiopulmonary bypass conventional therapy with a fixed insulin dosing scheme was initiated. If blood glucose was > 150 mg/dl, manual insulin therapy was started following a fixed insulin dosing scheme. Measurements of blood glucose were performed during surgery every 30 minutes, and on the ICU every 2 hours until discharge (Routine Care).
Intervention Type
Device
Intervention Name(s)
Space GlucoseControl System, B. Braun, Melsungen, Germany
Intervention Description
Computerized algorithmic application of insulin
Intervention Type
Other
Intervention Name(s)
Conventional therapy with a fixed insulin dosing scheme
Intervention Description
Routine care
Primary Outcome Measure Information:
Title
Time within a blood glucose corridor of 80 - 150 mg/dl
Description
The primary endpoint was defined as the time within a given blood glucose corridor from 80 - 150 mg/dl during therapy
Time Frame
From start of cardiopulmonary bypass during surgery until discharge from ICU, which is approximately after 48 -72 hrs.
Secondary Outcome Measure Information:
Title
Hypoglycemic events
Description
Secondary endpoints were the number of hypoglycemic events defined as blood glucose levels under 80 mg/dl
Time Frame
From beginning of cardiopulmonary bypass during surgery until discharge from the ICU, which is approximately after 48-72 hrs.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients over 18 scheduled for elective cardiac surgery with the use of cardiopulmonary bypass and blood cardioplegia
Exclusion Criteria:
under 18 years of age, or if patients had a premedical history of steroid therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel A Reuter, Professor
Organizational Affiliation
University Medical Center Hamburg-Eppendorf, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
25281044
Citation
Punke MA, Goepfert MS, Kluge S, Reichenspurner H, Goetz AE, Reuter DA. Perioperative glycemic control with a computerized algorithm versus conventional glycemic control in cardiac surgical patients undergoing cardiopulmonary bypass with blood cardioplegia. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1273-7. doi: 10.1053/j.jvca.2014.04.017.
Results Reference
derived
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Computerized Tight Glycemic Control in Cardiac Surgery
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