Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Three Protocols for Tight Glycemic Control in Cardiac Surgery Patients

Conditions
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Hyperglycemia

Intervention / Treatment
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* Drug: insulin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients admitted to the postoperative ICU after elective cardiac surgery Exclusion Criteria: insulin allergy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Matias protocol<br>A protocol based on the absolute glucose value - Matias protocol (Matias) | Drug: insulin<br>* Insulin was was administered according to each protocol rules/suggestions into a central venous line as a continuous infusion (Bath and eMPC protocols) or as a combination of a continuous infusion and boluses (Matias protocol). A standard concentration of 50 IU of insulin in 50 ml of 0.9% NaCl was used. In all patients, infusion of 10% glucose solution was initiated upon admission to ICU with glucose dose of 2.5 g/kg of ideal body weight (height in centimetres minus 100) per hour and lasted for 18 hours, when normal oral food intake was started. In ventilated patients, the glucose infusion lasted for 48 hours, and then standard enteral nutrition was initiated.<br>* Other names: Actrapid HM, Novo Nordisk, Baegsvard, Denmark;|
| Active Comparator: Bath protocol<br>A protocol based on the relative glucose change - Bath protocol (Bath) | Drug: insulin<br>* Insulin was was administered according to each protocol rules/suggestions into a central venous line as a continuous infusion (Bath and eMPC protocols) or as a combination of a continuous infusion and boluses (Matias protocol). A standard concentration of 50 IU of insulin in 50 ml of 0.9% NaCl was used. In all patients, infusion of 10% glucose solution was initiated upon admission to ICU with glucose dose of 2.5 g/kg of ideal body weight (height in centimetres minus 100) per hour and lasted for 18 hours, when normal oral food intake was started. In ventilated patients, the glucose infusion lasted for 48 hours, and then standard enteral nutrition was initiated.<br>* Other names: Actrapid HM, Novo Nordisk, Baegsvard, Denmark;|
| Active Comparator: eMPC<br>a computer-based model predictive control algorithm with variable sampling rate (eMPC) | Drug: insulin<br>* Insulin was was administered according to each protocol rules/suggestions into a central venous line as a continuous infusion (Bath and eMPC protocols) or as a combination of a continuous infusion and boluses (Matias protocol). A standard concentration of 50 IU of insulin in 50 ml of 0.9% NaCl was used. In all patients, infusion of 10% glucose solution was initiated upon admission to ICU with glucose dose of 2.5 g/kg of ideal body weight (height in centimetres minus 100) per hour and lasted for 18 hours, when normal oral food intake was started. In ventilated patients, the glucose infusion lasted for 48 hours, and then standard enteral nutrition was initiated.<br>* Other names: Actrapid HM, Novo Nordisk, Baegsvard, Denmark;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of different TGC management protocols |  | ICU stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety with respect to hypoglycemia |  | ICU stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tight glycemia control, cardiac surgery patients