Glucose Control by eMPC Algorithm in Peri- and Postoperative Period in Cardiac Surgery Patients

This study has been completed.
Sponsor:
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00444171
First received: March 5, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • Mean blood glucose
  • percentage of time in target range

Secondary Outcome Measures:
  • Number of hypoglycaemic episodes

Estimated Enrollment: 60
Study Start Date: September 2006
Estimated Study Completion Date: February 2007
Detailed Description:

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
Criteria

Inclusion Criteria:

  • Elective cardiac surgery

Exclusion Criteria:

  • Allergy against insulin
  • Mental incapacity
  • Language barrier
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00444171

Locations
Czech Republic
General University Hospital
Praha, Czech Republic, 12808
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
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
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 29, 2014