Blood Glucose Control Over an Extended Glucose Control Range in Postoperative Cardiac Surgery Patients in the Intensive Care Unit

Study Overview
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Brief Summary
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Hyperglycaemia is commonly found in critically ill patients. Clinical studies demonstrated that tight blood glucose control in medical and surgical ICU patients results in a significant better outcome for the patients. Based on this emerging clinical evidence, there are increasing efforts worldwide to maintain strict glycaemic control in critically ill patients. However, achieving this goal requires extensive nursing efforts, including frequent bedside glucose monitoring and the implementation of complex intensive insulin infusion protocols. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. This study will investigate the performance of an eMPC algorithm adjusted to target the range 4.4 - 8.3 mmol/L in line with the Surviving Sepsis guidelines.

Official Title
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Single-center, Open Study on the Performance of the Software eMPC Algorithm Used for Blood Glucose Control Over an Extended Glucose Control Range (4.4 to 8.3 mmol/L) for a Maximum of 48 Hours in Postoperative Cardiac Surgery Patients in the Intensive Care Unit

Conditions
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Critical Illness

Intervention / Treatment
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* Other: enhanced model predictive control algorithm (eMPC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: > 18 years of age Admitted following cardiac surgery Stay in the ICU expected to be > 20h Blood glucose > 6.7 mmol/l within 4 hours of admission to intensive care or patient already receiving insulin treatment Exclusion Criteria: Patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency. Known or suspected allergy to insulin Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e. liver failure, other fatal organ failures) Patients participating in another study Moribund patients likely to die within 24 hours Patients after organ transplantation within the last three months Patients under high dose cortisol treatment (cortisol > 1000 mg/day or equivalent doses of hydrocortisol)

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eMPC<br>improved model predictive control algorithm (eMPC) for glycaemic control in ICU patients | Other: enhanced model predictive control algorithm (eMPC)<br>* eMPC (software on a bedside computer) advised insulin titration to establish tight glycaemic control<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of time within the predefined glucose target range of 80-150 mg/dL |  | from start of treatment to the last glucose measurement under treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemias |  | from start of treatment to the last glucose measurement under treatment | 
| Usability parameters like convenience of alarming function; workload; blood sampling frequency |  | from start of treatment to the last glucose measurement under treatment | 
| Concomitant medication including insulin infusion rate, parenteral/enteral nutrition |  | from start of treatment to the last glucose measurement under treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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algorithm, tight glycemic control, glucose control, intensive care, insulin, ICU