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  1. Yahia A, Szlávecz Á, Knopp JL, Norfiza Abdul Razak N, Abu Samah A, Shaw G, et al.
    PMID: 34078114 DOI: 10.1177/19322968211018260
    BACKGROUND: Critically ill ICU patients frequently experience acute insulin resistance and increased endogenous glucose production, manifesting as stress-induced hyperglycemia and hyperinsulinemia. STAR (Stochastic TARgeted) is a glycemic control protocol, which directly manages inter- and intra- patient variability using model-based insulin sensitivity (SI). The model behind STAR assumes a population constant for endogenous glucose production (EGP), which is not otherwise identifiable.

    OBJECTIVE: This study analyses the effect of estimating EGP for ICU patients with very low SI (severe insulin resistance) and its impact on identified, model-based insulin sensitivity identification, modeling accuracy, and model-based glycemic clinical control.

    METHODS: Using clinical data from 717 STAR patients in 3 independent cohorts (Hungary, New Zealand, and Malaysia), insulin sensitivity, time of insulin resistance, and EGP values are analyzed. A method is presented to estimate EGP in the presence of non-physiologically low SI. Performance is assessed via model accuracy.

    RESULTS: Results show 22%-62% of patients experience 1+ episodes of severe insulin resistance, representing 0.87%-9.00% of hours. Episodes primarily occur in the first 24 h, matching clinical expectations. The Malaysian cohort is most affected. In this subset of hours, constant model-based EGP values can bias identified SI and increase blood glucose (BG) fitting error. Using the EGP estimation method presented in these constrained hours significantly reduced BG fitting errors.

    CONCLUSIONS: Patients early in ICU stay may have significantly increased EGP. Increasing modeled EGP in model-based glycemic control can improve control accuracy in these hours. The results provide new insight into the frequency and level of significantly increased EGP in critical illness.

  2. Abu-Samah A, Knopp JL, Abdul Razak NN, Razak AA, Jamaludin UK, Mohamad Suhaimi F, et al.
    Med Devices (Auckl), 2019;12:215-226.
    PMID: 31239792 DOI: 10.2147/MDER.S187840
    Background: Stress-induced hyperglycemia is common in critically ill patients. A few forms of model-based glycemic control have been introduced to reduce this phenomena and among them is the automated STAR protocol which has been used in the Christchurch and Gyulá hospitals' intensive care units (ICUs) since 2010. Methods: This article presents the pilot trial assessment of STAR protocol which has been implemented in the International Islamic University Malaysia Medical Centre (IIUMMC) Hospital ICU since December 2017. One hundred and forty-two patients who received STAR treatment for more than 20 hours were used in the assessment. The initial results are presented to discuss the ability to adopt and adapt the model-based control framework in a Malaysian environment by analyzing its performance and safety. Results: Overall, 60.7% of blood glucose measurements were in the target band. Only 0.78% and 0.02% of cohort measurements were below 4.0 mmol/L and 2.2 mmol/L (the limitsfor mild and severe hypoglycemia, respectively). Treatment preference-wise, the clinical staff were favorable of longer intervention options when available. However, 1 hourly treatments were still used in 73.7% of cases. Conclusion: The protocol succeeded in achieving patient-specific glycemic control while maintaining safety and was trusted by nurses to reduce workload. Its lower performance results, however, give the indication for modification in some of the control settings to better fit the Malaysian environment.
  3. Abdul Razak A, Abu-Samah A, Abdul Razak NN, Jamaludin U, Suhaimi F, Ralib A, et al.
    Med Devices (Auckl), 2020;13:139-149.
    PMID: 32607009 DOI: 10.2147/MDER.S231856
    Purpose: This paper presents an assessment of an automated and personalized stochastic targeted (STAR) glycemic control protocol compliance in Malaysian intensive care unit (ICU) patients to ensure an optimized usage.

    Patients and Methods: STAR proposes 1-3 hours treatment based on individual insulin sensitivity variation and history of blood glucose, insulin, and nutrition. A total of 136 patients recorded data from STAR pilot trial in Malaysia (2017-quarter of 2019*) were used in the study to identify the gap between chosen administered insulin and nutrition intervention as recommended by STAR, and the real intervention performed.

    Results: The results show the percentage of insulin compliance increased from 2017 to first quarter of 2019* and fluctuated in feed administrations. Overall compliance amounted to 98.8% and 97.7% for administered insulin and feed, respectively. There was higher average of 17 blood glucose measurements per day than in other centres that have been using STAR, but longer intervals were selected when recommended. Control safety and performance were similar for all periods showing no obvious correlation to compliance.

    Conclusion: The results indicate that STAR, an automated model-based protocol is positively accepted among the Malaysian ICU clinicians to automate glycemic control and the usage can be extended to other hospitals already. Performance could be improved with several propositions.

  4. Kim KT, Morton S, Howe S, Chiew YS, Knopp JL, Docherty P, et al.
    Trials, 2020 Feb 01;21(1):130.
    PMID: 32007099 DOI: 10.1186/s13063-019-4035-7
    BACKGROUND: Positive end-expiratory pressure (PEEP) at minimum respiratory elastance during mechanical ventilation (MV) in patients with acute respiratory distress syndrome (ARDS) may improve patient care and outcome. The Clinical utilisation of respiratory elastance (CURE) trial is a two-arm, randomised controlled trial (RCT) investigating the performance of PEEP selected at an objective, model-based minimal respiratory system elastance in patients with ARDS.

    METHODS AND DESIGN: The CURE RCT compares two groups of patients requiring invasive MV with a partial pressure of arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio ≤ 200; one criterion of the Berlin consensus definition of moderate (≤ 200) or severe (≤ 100) ARDS. All patients are ventilated using pressure controlled (bi-level) ventilation with tidal volume = 6-8 ml/kg. Patients randomised to the control group will have PEEP selected per standard practice (SPV). Patients randomised to the intervention will have PEEP selected based on a minimal elastance using a model-based computerised method. The CURE RCT is a single-centre trial in the intensive care unit (ICU) of Christchurch hospital, New Zealand, with a target sample size of 320 patients over a maximum of 3 years. The primary outcome is the area under the curve (AUC) ratio of arterial blood oxygenation to the fraction of inspired oxygen over time. Secondary outcomes include length of time of MV, ventilator-free days (VFD) up to 28 days, ICU and hospital length of stay, AUC of oxygen saturation (SpO2)/FiO2 during MV, number of desaturation events (SpO2 

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