Glucose Control by eMPC Algorithm in Peri- and Postoperative Period in Cardiac Surgery Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cardiac Surgery Patients Blood Glucose |
Procedure: insulin infusion rate controled by computer algorithm Procedure: insulin infusion rate guided by in-house glucose management protocol |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 60 |
| 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Elective cardiac surgery
Exclusion Criteria:
- Allergy against insulin
- Mental incapacity
- Language barrier
Contacts and Locations| Czech Republic | |
| General University Hospital | |
| Praha, Czech Republic, 12808 | |
| Principal Investigator: | Stepan Svacina, MD, DSc | Charles University Prague |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00444171 History of Changes |
| Other Study ID Numbers: | eMPC_CUP1 |
| Study First Received: | March 5, 2007 |
| Last Updated: | March 5, 2007 |
| Health Authority: | Czech Republic: Ministry of Health |
Keywords provided by Charles University, Czech Republic:
|
critically ill insulin resistance intensive insulin therapy computer algorithm |
Additional relevant MeSH terms:
|
Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013