Necrotizing Soft Tissue Infection Clinical Trial
Official title:
Biomarkers in Necrotizing Soft Tissue Infections - Effects of Hyperbaric Oxygen Treatment on the Immune Response
The purpose of this study is to investigate the effects of hyperic oxygen treatment on the immune response in patients with necrotizing soft tissue infections
Necrotizing soft tissue infections (NSTI) is a complex, multi-factorial disease and the
bacteria show a diverse microbial etiology. The exentisive inflammatory response caused by
these bacteria is thought to be a main course of death. In Denmark, most NSTI patients are
treated with hyperic oxygen therapy (HBOT). However, the effects of HBOT have never been
investigated in NSTI patients.
Location: Copenhagen University Hospital, Rigshospitalet, Denmark.
Design: Observational cohort study.
Cohort: NSTI patients in Denmark treated with HBOT.
Biomarkers: Cytokines, acute-phase proteins, vasoactive biomarkers and other inflammatory
biomarkers.
Sample size calculation: The investigators expect a mean IL-6 concentration before HBOT of
3500 pg/ml (standard deviation 1500 pg/ml) and consider a reduction of 800 pg/ml to be
clinically relevant. With an alpha = 0.05 and a power of 80%, 112 patients will be required.
Data: The Danish Data Protection Agency has approved the processing of personal data for the
NSTI patients (J. no. 30-0900).
Ethics: The trial will adhere to the Helsinki Declaration and the Danish law. The National
Ethics Committee and the Regional Scientific Ethics Committee of Copenhagen have approved the
study (CVK-1211709 and H-2-2014-071).
Analysis: Biomarker analyses will be performed once the recruitment of patients has ended.
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