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