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| Name | Class |
|---|---|
| B. Braun Melsungen AG | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | 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. |
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| Group B | Active Comparator | 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. |
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| Group C | Other | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Space GlucoseControl System, B. Braun, Melsungen, Germany | Device | Computerized algorithmic application of insulin |
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| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel A Reuter, Professor | University Medical Center Hamburg-Eppendorf, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Hamburg-Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20246 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37526194 | Derived | Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3. | |
| 25281044 | Derived | 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. |
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| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
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| Conventional therapy with a fixed insulin dosing scheme | Other | Routine care |
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