Tight Glycemic Control by eMPC Algorithm in Medical ICU Patients.
Condition: Critically Ill Patients; Mechanical Ventilation; Hyperglycemia
MeSH terms: Hyperglycemia; Critical Illness
Study type: Interventional

Summary: 
      This is an open mono-centre randomised controlled trial performed at the Medical University
      Graz including a treatment visit (V1). In the treatment visit (V1) after admittance to the
      ICU arterial blood glucose values will be monitored and either the software-algorithm eMPC
      will be used to adjust the infusion rate of intravenously administered human soluble insulin
      to normalise arterial blood glucose or routine treatment will be used to establish tight
      glycaemic control. The treatment visit will last for 72 hours.

      The primary hypothesis of the study is that blood glucose control by the eMPC algorithm is
      not inferior compared to the implemented routine protocol.
    

Detailed description: 
      Hyperglycaemia is commonly found in critically ill patients. The stress of critical illness
      induces glucose counterregulatory hormones and a number of alterations in carbohydrate
      metabolism, including increased peripheral glucose demands, enhanced hepatic glucose
      production, insulin resistance and relative insulin deficiency. Moreover, clinical
      interventions, such as corticoids, vasopressors, and enteral or parenteral nutrition, further
      predispose these patients to elevated blood glucose levels. In patients in intensive care as
      well as in general hospital settings patients with hyperglycemia have higher mortality rates.
      Recent studies demonstrated that tight blood glucose control in ICU patients results in a
      significant better outcome for the patients.

      Based on this emerging clinical evidence, there are increasing efforts world-wide 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 and such increased work
      demands may not be readily accepted by a busy ICU nursing staff.

      The development of a closed loop control system that automatically infuses insulin on the
      basis of glucose measurements could permit strict glycaemic control and improve clinical
      outcome without increasing workload of the ICU nursing staff. The EU founded project CLINICIP
      (Closed Loop Infusion in Critically ill patients) aims to develop a low-risk monitoring and
      control system which allows maintaining metabolic control in intensive care units. As a first
      step a local bedside semi-closed system will be developed. Based on arterial spot
      measurement, an adaptive control algorithm will generate advice and thus represent a decision
      supporting system for the ICU nursing staff. This control algorithm was adapted for patients
      in the ICU. The first study using this algorithm was performed at the Medical University
      Hospital in Graz. In all six patients, who were included in this feasibility trial, blood
      glucose levels could be normalised and maintained in the narrow target range for up to 24
      hours without a single hypoglycaemic episode. Subsequently, the algorithm was tested in a
      multicentric randomized controlled trial setting and showed superiority by means of a reduced
      number of hypoglycaemic events and a higher percentage of glucose values within the target
      range as compared to routine care glucose management protocols. In this study it was a fact
      that the hourly sampling frequency in the algorithm group has positively influenced the
      outcome in the algorithm group. Therefore in an enhanced version of the algorithm (eMPC) the
      sampling interval is expanded up to 240 min.

      The purpose of this study is to evaluate the feasibility of this enhanced model predictive
      control algorithm for glycaemic control in critically ill patients compared to routine
      treatment.
    

Intervention name(s): insulin titration applying a computer algorithm
Intervention type(s): Procedure
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: algorithm; insulin; hyperglycemia; tight glycemic control; intensive care; adults