M B Madsen1, S Skrede2,3, T Bruun2, P Arnell4, A Rosén4, M Nekludov5, Y Karlsson6, F Bergey7, E Saccenti8, V A P Martins Dos Santos7,8, A Perner1, A Norrby-Teglund9, O Hyldegaard10. 1. Department of Intensive Care, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. 2. Department of Medicine, Haukeland University Hospital, Bergen, Norway. 3. Department of Clinical Science, University of Bergen, Bergen, Norway. 4. Department of Anaesthesia and Intensive Care, Sahlgrenska University Hospital, Gothenburg, Sweden. 5. Department of Anaesthesia, Surgical Services and Intensive Care, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden. 6. Department of Anaesthesiology and Intensive Care, Blekinge County Hospital, Karlskrona, Sweden. 7. LifeGlimmer GmBH, Berlin, Germany. 8. Laboratory of Systems and Synthetic Biology, Wageningen University & Research, Wageningen, the Netherlands. 9. Centre for Infectious Medicine, Karolinska Institutet, Karolinska University Hospital, Huddinge, Sweden. 10. Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Abstract
BACKGROUND: The INFECT project aims to advance our understanding of the pathophysiological mechanisms in necrotizing soft tissue infections (NSTIs). The INFECT observational study is part of the INFECT project with the aim of studying the clinical profile of patients with NSTIs 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 NSTIs are enrolled in five Scandinavian hospitals, which are all referral centres for NSTIs. 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 NSTIs to date and will provide important data for clinicians, researchers and policy makers on the characteristics and outcomes of these patients.
BACKGROUND: The INFECT project aims to advance our understanding of the pathophysiological mechanisms in necrotizing soft tissue infections (NSTIs). The INFECT observational study is part of the INFECT project with the aim of studying the clinical profile of patients with NSTIs 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 NSTIs are enrolled in five Scandinavian hospitals, which are all referral centres for NSTIs. 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 NSTIs to date and will provide important data for clinicians, researchers and policy makers on the characteristics and outcomes of these patients.
Authors: Martin Bruun Madsen; Steinar Skrede; Anders Perner; Per Arnell; Michael Nekludov; Trond Bruun; Ylva Karlsson; Marco Bo Hansen; Peter Polzik; Morten Hedetoft; Anders Rosén; Edoardo Saccenti; François Bergey; Vitor A P Martins Dos Santos; Anna Norrby-Teglund; Ole Hyldegaard Journal: Intensive Care Med Date: 2019-08-22 Impact factor: 17.440
Authors: Robert Thänert; Andreas Itzek; Jörn Hoßmann; Domenica Hamisch; Martin Bruun Madsen; Ole Hyldegaard; Steinar Skrede; Trond Bruun; Anna Norrby-Teglund; Eva Medina; Dietmar H Pieper Journal: Nat Commun Date: 2019-08-26 Impact factor: 14.919
Authors: Morten Hedetoft; Marco Bo Hansen; Martin Bruun Madsen; Julia Sidenius Johansen; Ole Hyldegaard Journal: BMC Infect Dis Date: 2021-10-09 Impact factor: 3.090
Authors: Dag Harald Skutlaberg; Harald G Wiker; Haima Mylvaganam; Anna Norrby-Teglund; Steinar Skrede Journal: Front Microbiol Date: 2022-02-18 Impact factor: 5.640