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

• Sponsor: Charles University, Czech Republic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00444171
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 11.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Cardiac Surgery Patients; Blood Glucose	Procedure: insulin infusion rate controled by computer algorithm; Procedure: insulin infusion rate guided by in-house glucose management protocol	N/A

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.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Sep 1, 2006
• Study Completion Date: Feb 1, 2007

Outcome Measures

Primary Outcome Measures

1. Mean blood glucose []

2. percentage of time in target range []

Secondary Outcome Measures

1. Number of hypoglycaemic episodes []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Elective cardiac surgery

Exclusion Criteria:

• Allergy against insulin

• Mental incapacity

• Language barrier

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General University Hospital	Praha		Czech Republic	12808

Sponsors and Collaborators

• Charles University, Czech Republic

Investigators

• Principal Investigator: Stepan Svacina, MD, DSc, Charles University Prague

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00444171
• Other Study ID Numbers: eMPC_CUP1
• First Posted: Mar 7, 2007
• Last Update Posted: Mar 7, 2007
• Last Verified: Mar 1, 2007

• Keywords provided by , ,: critically ill; insulin resistance; intensive insulin therapy; computer algorithm
• Additional relevant MeSH terms: Insulin; Insulin, Globin Zinc

Study Results

No Results Posted as of Mar 7, 2007