Computerized Tight Glycemic Control in Cardiac Surgery

Not Applicable

Completed

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

• Registration Number: NCT01886365
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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 Timeline

• Study Start: 2011-10
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-06
• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-24
• Last Update Submitted: 2013-06-24
• Study First Posted: 2013-06-25
• Last Update Posted: 2013-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Space GlucoseControl System, B. Braun, Melsungen, Germany	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.
Group B	Space GlucoseControl System, B. Braun, Melsungen, Germany	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.
Group C	Conventional therapy with a fixed insulin dosing scheme	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).

Primary Outcome Measures

Name	Time	Method
Time within a blood glucose corridor of 80 - 150 mg/dl	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 Outcome Measures

Name	Time	Method
Hypoglycemic events	From beginning of cardiopulmonary bypass during surgery until discharge from the ICU, which is approximately after 48-72 hrs.	Secondary endpoints were the number of hypoglycemic events defined as blood glucose levels under 80 mg/dl

Trial Locations

Locations (1)

University Medical Center Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany