Computerized Tight Glycemic Control in Cardiac Surgery

Universitätsklinikum Hamburg-Eppendorf

Status: Completed

Conditions: Hyperglycemia

Treatments: Device: Space GlucoseControl System, B. Braun, Melsungen, Germany; Other: Conventional therapy with a fixed insulin dosing scheme

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01886365

PV3388

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Group A

Active Comparator group

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.

Treatment:

Device: Space GlucoseControl System, B. Braun, Melsungen, Germany

Group B

Active Comparator group

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.

Treatment:

Device: Space GlucoseControl System, B. Braun, Melsungen, Germany

Group C

Other group

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).

Treatment:

Other: Conventional therapy with a fixed insulin dosing scheme