An observational study in Necrotizing Soft Tissue Infection, Necrotizing Fasciitis and Gas Gangrene, sponsored by Ole Hyldegaard. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-24.
Sponsored by Ole Hyldegaard · Observational
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.
28 studies on the registry are indexed under Fasciitis, Necrotizing; 8 are open to participants now.
This study's enrollment of 65 is below the median of 152 across 16 observational studies indexed under Fasciitis, Necrotizing.
Browse Fasciitis, Necrotizing studies →Ole Hyldegaard is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Patients with NSTI treated with HBOT
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
NSTI definition: An infection that requires acute hospitalization with intensive care treatment and/or surgery as a consequence of severe soft tissue infection causing necrosis in subcutis, muscle and/or fascia.
IL-6 as a marker of treatment effects after HBOT
Time frame: Change from baseline in IL-6 concentration after first HBOT administered during the first 24 hours of admission
Inflammatory biomarkers as indicators of treatment effects after HBOT
Time frame: The first 5 days of admission
Vasoactive biomarkers as indicators of treatment effects after HBOT
Time frame: The first 5 days of admission
Mortality
Time frame: 30, 90, 180 days
Amputation rate
Time frame: During the first 7 days of ICU admission
SAPS II assessment
Time frame: During the first 24 hours of ICU admission
APACHE II assessment
Time frame: During the first 7 days of ICU admission
SOFA score assessment
Time frame: During the first 7 days of ICU admission
Anaya score assessment
Time frame: During the first 7 days of ICU admission
LRINEC score assessment
Time frame: During the first 7 days of ICU admission
Multiple organ failure assessed by the MODS score
Time frame: During the first 7 days of ICU admission
Number of debridements
Time frame: During the first 7 days of ICU admission
Microbial etiology results from blood and tissue samples
Time frame: During the first 7 days of ICU admission
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Ole Hyldegaard