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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with NSTI treated with HBOT | 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. |
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| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory biomarkers as indicators of treatment effects after HBOT | The first 5 days of admission | |
| Vasoactive biomarkers as indicators of treatment effects after HBOT | The first 5 days of admission |
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Inclusion criteria:
Exclusion criteria:
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Patients with NSTI treated with HBOT
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| Name | Affiliation | Role |
|---|---|---|
| Ole Hyldegaard, MD, PhD | Department of Anaesthesiology, Center of Hyperbaric Treatment, sect. 4092, Copenhagen University Hospital, Denmark | Study Director |
| Marco Bo Hansen, MD | Department of Anaesthesiology, Center of Hyperbaric Treatment, sect. 4092, Copenhagen University Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Rigshospitalet | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D019115 | Fasciitis, Necrotizing |
| D005738 | Gas Gangrene |
| D018934 | Fournier Gangrene |
| D005208 | Fasciitis |
| D018461 | Soft Tissue Infections |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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Whole blood and plasma/serum
| 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 |
| SOFA score assessment | During the first 7 days of ICU 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 |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |