Glucose Control by eMPC Algorithm in Peri- and Postoperative Period in Cardiac Surgery Patients
Randomized controlled trial to compare blood glucose control by the model predictive control algorithm with variable sampling rate (eMPC) with routine glucose management protocol (RMP) in peri- and postoperative period in cardiac surgery patients.
Cardiac Surgery Patients
Procedure: insulin infusion rate controled by computer algorithm
Procedure: insulin infusion rate guided by in-house glucose management protocol
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Randomized Controlled Trial to Evaluate Blood Glucose Control by the Model Predictive Control Algorithm With Variable Sampling Rate (eMPC) vs. Routine Glucose Management Protocol in Peri- and Postoperative Period in Cardiac Surgery Patients|
- Mean blood glucose
- percentage of time in target range
- Number of hypoglycaemic episodes
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||February 2007|
Context. Increased blood glucose levels frequently occur in critically ill patients and its normalization by intensive insulin treatment markedly improves clinical outcome.
Objective and Design: Randomized controlled trial to compare blood glucose control by the model predictive control algorithm with variable sampling rate (eMPC) with routine glucose management protocol (RMP) in peri- and postoperative period in cardiac surgery patients.
Setting: Department of Cardiac Surgery, University Hospital. Patients. 60 cardiac surgery patients. Interventions. Elective cardiac surgery and treatment with continuous insulin infusion to maintain euglycemia (target range 4.4 – 6.1 mmol/l). 30 patients were randomized for eMPC and 30 for RMP treatment. Blood glucose was measured in 1-4 hour intervals depending on request of each algorithm during surgery and post-operation period for 24 hours.
Main Outcome Measures. Mean blood glucose, percentage of time in target range. Results. Mean blood glucose was 6.15 ± 1.11 mmol/l in eMPC vs. 7.21 ± 1.08 mmol/l in RMP group (p<0.05); percentage of time in target range was 60.4 ± 22.8% for eMPC vs. 27.5 ± 16.2% for RMP group (p<0.05). No severe hypoglycemia (blood glucose bellow 2.9 mmol/l) was observed during the study. Average insulin infusion rate was 4.67 ± 3.34 in eMPC vs. 2.57 ± 1.66 IU/h in RMP (p<0.05), average sampling interval was 1.46 ± 0.31 vs. 2.10 ± 0.22 hours (p<0.05).
Conclusions. eMPC algorithm was more effective and comparably safe as compared to RMP in maintaining euglycemia in cardiac surgery patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00444171
|General University Hospital|
|Praha, Czech Republic, 12808|
|Principal Investigator:||Stepan Svacina, MD, DSc||Charles University Prague|