NCT01886365

Computerized Tight Glycemic Control in Cardiac Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyperglycemia

Interventions

Type	Name	Description
DEVICE	Space GlucoseControl System, B. Braun, Melsungen, Germany	Computerized algorithmic application of insulin
OTHER	Conventional therapy with a fixed insulin dosing scheme	Routine care

Timeline

• Start date: 2011-10-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2013-06-25
• Last updated: 2013-06-25

Locations

1 site across 1 country: Germany