Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment (BIONEC-II)
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|ClinicalTrials.gov Identifier: NCT02501382|
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : June 24, 2019
|Condition or disease|
|Necrotizing Soft Tissue Infection Necrotizing Fasciitis Gas Gangrene Fournier Gangrene|
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.
|Study Type :||Observational|
|Actual Enrollment :||65 participants|
|Official Title:||Biomarkers in Necrotizing Soft Tissue Infections - Effects of Hyperbaric Oxygen Treatment on the Immune Response|
|Actual Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 1, 2015|
|Actual Study Completion Date :||December 1, 2015|
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.
- 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 ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501382
|Copenhagen University Hospital, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Study Director:||Ole Hyldegaard, MD, PhD||Department of Anaesthesiology, Center of Hyperbaric Treatment, sect. 4092, Copenhagen University Hospital, Denmark|
|Principal Investigator:||Marco Bo Hansen, MD||Department of Anaesthesiology, Center of Hyperbaric Treatment, sect. 4092, Copenhagen University Hospital, Denmark|