Fournier Gangrene, Gas Gangrene, Necrotizing Fasciitis, Necrotizing Soft Tissue Infection
Conditions
Keywords
Fasciitis, Fasciitis, Necrotizing, Soft tissue infections, Fournier's gangrene, Immunopathogenesis
Brief summary
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
Detailed 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.
Interventions
None listed
Sponsors
Ole Hyldegaard
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Necrotizing soft tissue infection based on surgical findings * Admitted to/planned to be admitted to the ICU at Rigshospitalet and/or operated for NSTI at Rigshospitalet * Receving a minimum of 1 HBOT
Exclusion criteria
* Patients who at the operating theatre were categorized as a non-NSTI patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IL-6 as a marker of treatment effects after HBOT | Change from baseline in IL-6 concentration after first HBOT administered during the first 24 hours of admission |
Secondary
| Measure | Time frame |
|---|---|
| Vasoactive biomarkers as indicators of treatment effects after HBOT | The first 5 days of admission |
| Mortality | 30, 90, 180 days |
| Amputation rate | During the first 7 days of ICU admission |
| SAPS II assessment | During the first 24 hours of ICU admission |
| APACHE II assessment | During the first 7 days of ICU admission |
| Inflammatory biomarkers as indicators of treatment effects after HBOT | The first 5 days of admission |
| Anaya score assessment | During the first 7 days of ICU admission |
| LRINEC score assessment | During the first 7 days of ICU admission |
| Multiple organ failure assessed by the MODS score | During the first 7 days of ICU admission |
| Number of debridements | During the first 7 days of ICU admission |
| Microbial etiology results from blood and tissue samples | During the first 7 days of ICU admission |
| SOFA score assessment | During the first 7 days of ICU admission |
Countries
Denmark
Outcome results
None listed