Biomarkers in Necrotizing Soft Tissue Infections – Effects of Hyperbaric Oxygen Treatment on the Immune Response
Description:
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.
Condition:
Necrotizing Soft Tissue Infection
Treatment:
Start Date:
February 2013
Sponsor:
Ole Hyldegaard
For More Information:
https://clinicaltrials.gov/show/NCT02501382