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Necrotizing soft tissue infections – a multicentre, prospective observational study ( INFECT ): protocol and statistical analysis plan
Author(s) -
Madsen M. B.,
Skrede S.,
Bruun T.,
Arnell P.,
Rosén A.,
Nekludov M.,
Karlsson Y.,
Bergey F.,
Saccenti E.,
Martins dos Santos V. A. P.,
Perner A.,
NorrbyTeglund A.,
Hyldegaard O.
Publication year - 2018
Publication title -
acta anaesthesiologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.738
H-Index - 107
eISSN - 1399-6576
pISSN - 0001-5172
DOI - 10.1111/aas.13024
Subject(s) - medicine , observational study , fasciitis , univariate analysis , prospective cohort study , referral , emergency medicine , intensive care medicine , surgery , multivariate analysis , family medicine
Background The INFECT project aims to advance our understanding of the pathophysiological mechanisms in necrotizing soft tissue infections ( NSTI s). The INFECT observational study is part of the INFECT project with the aim of studying the clinical profile of patients with NSTI s and correlating these to patient‐important outcomes. With this protocol and statistical analysis plan we describe the methods used to obtain data and the details of the planned analyses. Methods The INFECT study is a multicentre, prospective observational cohort study. Patients with NSTI s are enrolled in five Scandinavian hospitals, which are all referral centres for NSTI s. The primary outcomes are the descriptive variables of the patients. Secondary outcomes include identification of factors associated with 90‐day mortality and amputation; associations between affected body part, maximum skin defect and Laboratory Risk Indicator for Necrotizing Fasciitis ( LRINEC ) score and 90‐day mortality; 90‐day mortality in patients with and without acute kidney injury ( AKI ) and LRINEC score of six and above or below six; and association between affected body part at arrival and microbiological findings. Exploratory outcomes include univariate analyses of baseline characteristics associations with 90‐day mortality. The statistical analyses will be conducted in accordance with the predefined statistical analysis plan. Conclusion Necrotizing soft tissue infections result in severe morbidity and mortality. The INFECT study will be the largest prospective study in patients with NSTI s to date and will provide important data for clinicians, researchers and policy makers on the characteristics and outcomes of these patients.