Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment (BIONEC-II)

Biomarkers in Necrotizing Soft Tissue Infections - Effects of Hyperbaric Oxygen Treatment on the Immune Response

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

Study Overview

• Status: Completed
• Conditions: Fournier Gangrene; Necrotizing Soft Tissue Infection; Necrotizing Fasciitis; Gas Gangrene

Detailed Description

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
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital, Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with NSTI treated with HBOT

Description

Inclusion criteria:

• 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

Exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Ole Hyldegaard
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 3, 2015
• First Submitted That Met QC Criteria: July 15, 2015
• First Posted (Estimate): July 17, 2015

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Fasciitis; Fasciitis, Necrotizing; Immunopathogenesis; Soft tissue infections; Fournier's gangrene
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Disease Attributes; Musculoskeletal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Clostridium Infections; Infections; Communicable Diseases; Soft Tissue Infections; Gangrene; Fasciitis; Fournier Gangrene; Gas Gangrene; Fasciitis, Necrotizing
• Other Study ID Numbers: BIONEC2-MBH-2015