Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment

NCT02501382 | Completed DMC

• 1 other identifier: BIONEC2-MBH-2015
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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

Conditions

Necrotizing Soft Tissue Infection; Necrotizing Fasciitis; Gas Gangrene; Fournier Gangrene

Keywords

Fasciitis; Fasciitis, Necrotizing; Soft tissue infections; Fournier's gangrene; Immunopathogenesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with NSTI treated with HBOT

You may qualify if:

• 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

You may not qualify if:

• Patients who at the operating theatre were categorized as a non-NSTI patient

Sponsors & Collaborators

• Ole Hyldegaard: lead

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and plasma/serum

MeSH Terms

Conditions

Fasciitis, Necrotizing; Gas Gangrene; Fournier Gangrene; Fasciitis; Soft Tissue Infections

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, DMSci

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 17, 2015
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 24, 2019

Record last verified: 2019-06

Locations

DK (1)