• Acta Anaesthesiol Scand · Sep 2018

    Diabetes and necrotizing soft tissue infections-A prospective observational cohort study: Statistical analysis plan.

    • A Rosén, P Arnell, M B Madsen, B G Nedrebø, A Norrby-Teglund, O Hyldegaard, V M Dos Santos, F Bergey, E Saccenti, INFECT Study Group, and S Skrede.
    • Department of Anaesthesia and Intensive Care Medicine, Sahlgrenska University Hospital/Ostra, Gothenburg, Sweden.
    • Acta Anaesthesiol Scand. 2018 Sep 1; 62 (8): 117111771171-1177.

    BackgroundNecrotizing soft tissue infections (NSTIs) are rare but carry a high morbidity and mortality. The multicenter INFECT project aims to improve the understanding of the pathogenesis, clinical characteristics, diagnosis, and prognosis of NSTIs. This article describes the study outline and statistical analyses that will be used.MethodsWithin the framework of INFECT project, patients with NSTI at 5 Scandinavian hospitals are enrolled in a prospective observational cohort study. The goal is to evaluate outcome and characteristics for patients with NSTI and diabetes compared to patients with NSTI without diabetes. The primary outcome is mortality at 90 days after inclusion. Secondary outcomes include days alive and out of ICU and hospital, SAPS II, SOFA score, infectious etiology, amputation, affected body area, and renal replacement therapy. Comparison in mortality between patients with diabetes type 1 and 2 as well as between insulin-treated and non-insulin-treated diabetes patients will be made. Clinical data for diabetic patients with NSTI will be reported.ConclusionThe study will provide important data on patients with NSTI and diabetes.© 2018 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

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