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  • 标题:STAR-3D Clinical Trial Results: Improved performance and safety
  • 本地全文:下载
  • 作者:Vincent Uyttendaele ; Jennifer L. Knopp ; Thomas Desaive
  • 期刊名称:IFAC PapersOnLine
  • 印刷版ISSN:2405-8963
  • 出版年度:2021
  • 卷号:54
  • 期号:15
  • 页码:490-495
  • DOI:10.1016/j.ifacol.2021.10.304
  • 语种:English
  • 出版社:Elsevier
  • 摘要:AbstractGlycemic control (GC) has improved outcomes for intensive care unit (ICU) patients. However, the increased risk of hypoglycemia and glycemic variability due to inter- and intra- patient variability make safe, effective GC difficult. Stochastic TARgeted (STAR) GC framework is a unique, patient-specific, risk-based dosing protocol directly accounting for both inter- and intra- patient variability using a stochastic model of future patient variability. A new tri-variate (3D) stochastic model, developed and validated in virtual trials to provide more accurate future predictions of insulin sensitivity (SI), is clinically evaluated.STAR-3D was implemented as standard care at the Christchurch Hospital ICU, New Zealand, between April 2019 and January 2021. In total, 567 patients (33276 hours) were treated. The overall median [IQR] BG achieved was 6.7 [6.0 7.8] mmol/L with 76% BG in the 4.4-8.0 mmol/L target band. Importantly, there were only 0.3% BG < 4.0 mmol/L (mild hypoglycemia) and no incidence of severe hypoglycemia (BG < 2.2 mmol/L). These outcomes were achieved with median [IQR] 4.0 [2.0 6.0] U/h insulin and median [IQR] nutrition delivery of 99 [80 100]% goal feed (GF). Similar safety and performance BG outcomes were obtained at a per-patient level, suggesting STAR-3D successfully provided safe, effective control for all patients, regardless of patient condition. Compared to the original version of STAR, STAR-3D provided improved safety and efficacy, while achieving higher nutrition delivery.The new 3D stochastic model in STAR-3D provided higher safety and efficacy for all patients in this large clinical trial, despite using higher insulin rates than its predecessor to provide greater nutrition delivery. STAR-3D thus better captured patient-specific condition and variability to provide improved GC outcomes.
  • 关键词:KeywordsGlycemic ControlHyperglycemiaHypoglycemiaInsulinClinical TrialIntensive Care
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