Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients
- Registration Number
- NCT00764712
- Lead Sponsor
- Charles University, Czech Republic
- Brief Summary
A randomized trial to compare three insulin-titration protocols for tight glycemic control in surgical ICU: an absolute glucose (Matias) protocol, a relative glucose change (Bath) protocol, and an enhanced model predictive control algorithm (eMPC)
- Detailed Description
120 consecutive post-cardiac surgery patients randomized to the three protocols with a target glycemia range from 4.4 to 6.1 mmol/l. Intravenous insulin was administered continuously or in combination with insulin boluses (Matias protocol). Blood glucose was measured in 1-4 hour intervals as requested by protocols.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- patients admitted to the postoperative ICU after elective cardiac surgery
Exclusion Criteria
- insulin allergy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bath protocol insulin A protocol based on the relative glucose change - Bath protocol (Bath) Matias protocol insulin A protocol based on the absolute glucose value - Matias protocol (Matias) eMPC insulin a computer-based model predictive control algorithm with variable sampling rate (eMPC)
- Primary Outcome Measures
Name Time Method The effectiveness of different TGC management protocols ICU stay
- Secondary Outcome Measures
Name Time Method The safety with respect to hypoglycemia ICU stay
Trial Locations
- Locations (1)
University Hospital in Prague
🇨🇿Prague, Czech Republic