Glucose Control by eMPC Algorithm in Peri- and Postoperative Period in Cardiac Surgery Patients
NCT ID: NCT00444171
Last Updated: 2007-03-07
Study Results
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Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2006-09-30
2007-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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insulin infusion rate controled by computer algorithm
insulin infusion rate guided by in-house glucose management protocol
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Mental incapacity
* Language barrier
ALL
No
Sponsors
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Charles University, Czech Republic
OTHER
Principal Investigators
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Stepan Svacina, MD, DSc
Role: PRINCIPAL_INVESTIGATOR
Charles University Prague
Locations
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General University Hospital
Prague, , Czechia
Countries
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Other Identifiers
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eMPC_CUP1
Identifier Type: -
Identifier Source: org_study_id
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