Clinical Trial: Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Biomarkers in Necrotizing Soft Tissue Infections - Effects of Hyperbaric Oxygen Treatment on the Immune Response
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 Summary:
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.
Sponsor: Ole Hyldegaard
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Rigshospitalet, Denmark
Dates:
Date Received: July 3, 2015
Date Started: February 2013
Date Completion: December 2016
Last Updated: July 15, 2015
Last Verified: July 2015