Computerized Tight Glycemic Control in Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Perioperative Glycemic Control With a Computerized Algorithm vs. Conventional Glycemic Control in Cardio-surgical Patients Undergoing Cardiopulmonary Bypass With Blood Cardioplegia

Conditions
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Hyperglycemia

Intervention / Treatment
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* Device: Space GlucoseControl System, B. Braun, Melsungen, Germany
* Other: Conventional therapy with a fixed insulin dosing scheme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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. | Device: Space GlucoseControl System, B. Braun, Melsungen, Germany<br>* Computerized algorithmic application of insulin<br>|
| Active Comparator: Group B<br>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. | Device: Space GlucoseControl System, B. Braun, Melsungen, Germany<br>* Computerized algorithmic application of insulin<br>|
| Other: Group C<br>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). | Other: Conventional therapy with a fixed insulin dosing scheme<br>* Routine care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | From start of cardiopulmonary bypass during surgery until discharge from ICU, which is approximately after 48 -72 hrs. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemic events | Secondary endpoints were the number of hypoglycemic events defined as blood glucose levels under 80 mg/dl | From beginning of cardiopulmonary bypass during surgery until discharge from the ICU, which is approximately after 48-72 hrs. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computer based glycemic control, insulin, blood glucose