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Uyttendaele, Vincent; Dickson, Jennifer L.; Shaw, Geoffrey; Desaive, Thomas; Chase, J. Geoffrey
IFAC-PapersOnLine, 07/2017, Letnik: 50, Številka: 1Journal Article, Web Resource, Conference Proceeding
Hypoglycaemia, hyperglycaemia and blood glucose (BG) variability are associated with worsened outcomes in critical care. However, NICE-SUGAR trial showed no clinical benefit from intensive insulin therapy. This study compares the table-based NICE-SUGAR and model-based STAR protocols to assess their relative capability to achieve safe, effective control for all patients. Validated virtual patients (n=443) were used to simulate glycaemic outcomes of the NICE-SUGAR and STAR protocols. Key outcomes evaluate tightness and safety of control for all patients: %BG in 80–144 mg/dL range (PTR); Per-Patient Mean BG (PPM_BG); and Incidence of Hypoglycaemia (BG<40 mg/dL). These metrics determine performance overall, for each patient, and safety. Results are assessed for NICE-SUGAR measuring per-protocol (~24/day) and at reported average rate (~3-hourly; ~8/day). STAR measures 1-3-hourly, averaging 12/day. Per-protocol, STAR provided tight control, with higher PTR (90.7% vs. 78.3%) and tighter median IQR PPM_BG (112106-119 vs. 117106–137 mg/dL), and greater safety from hypoglycaemia (5 (1%) vs. 10 patients (2.5%)) compared to NICE-SUGAR simulations as per protocol. The 5-95th percentile range PPM_BG for NICE-SUGAR (97–185 mg/dL) showed ~5% of NICE-SUGAR patients had mean BG above 180mg/dL matching clinically reported performance. STAR’s 5th-90th PPM_BG percentile range was (97–146 mg/dL). Measuring as recorded clinically, NICE-SUGAR had PTR of 77%, PPM_BG of 122 110-140 mg/dL and 24(6%) of patients experienced hypoglycaemia. These results match clinically reported values well (mean BG 115 vs. 118 mg/dL clinically vs. simulation, clinically 7% of patients had a hypoglycaemic event). Glycaemic control protocols need to be both safe and effective for all patients before potential clinical benefits can be assessed. NICE-SUGAR clinical results do not match results expected from their protocol, and show reduced safety and performance in comparison to STAR.
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Leto | Faktor vpliva | Izdaja | Kategorija | Razvrstitev | ||||
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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in: SICRIS
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