Perioperative Glycemic Control With a Computerized Algorithm vs. Conventional Glycemic Control in Cardio-surgical Patients Undergoing Cardiopulmonary Bypass With Blood Cardioplegia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Time within a blood glucose corridor of 80 - 150 mg/dl
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group A
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.
Intervention: Space GlucoseControl System, B. Braun, Melsungen, Germany (Device)
Group B
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.
Intervention: Space GlucoseControl System, B. Braun, Melsungen, Germany (Device)
Group C
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).
Intervention: Conventional therapy with a fixed insulin dosing scheme (Other)
Outcomes
Primary Outcomes
Time within a blood glucose corridor of 80 - 150 mg/dl
Time Frame: From start of cardiopulmonary bypass during surgery until discharge from ICU, which is approximately after 48 -72 hrs.
The primary endpoint was defined as the time within a given blood glucose corridor from 80 - 150 mg/dl during therapy
Secondary Outcomes
- Hypoglycemic events(From beginning of cardiopulmonary bypass during surgery until discharge from the ICU, which is approximately after 48-72 hrs.)
Investigators
Prof. Dr. med. Daniel Reuter
Professor of anesthesiology
Universitätsklinikum Hamburg-Eppendorf