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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
Computerized algorithmic application of insulin
Routine care
University Medical Center Hamburg-Eppendorf
Hamburg, Hamburg, Germany
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
Time frame: From start of cardiopulmonary bypass during surgery until discharge from ICU, which is approximately after 48 -72 hrs.
Hypoglycemic events
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.
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