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

Completed

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

• Registration Number: NCT02501382
• Lead Sponsor: Ole Hyldegaard

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 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 Timeline

• Study Start: 2013-02
• Study First Submitted: 2015-07-03
• Study First Submitted QC: 2015-07-15
• Study First Posted: 2015-07-17
• Primary Completion: 2015-12-01
• Study Completion: 2015-12-01
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-20
• Last Update Posted: 2019-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mortality	30, 90, 180 days
Inflammatory biomarkers as indicators of treatment effects after HBOT	The first 5 days of admission
APACHE II assessment	During the first 7 days of ICU admission
SOFA score assessment	During the first 7 days of ICU admission
Microbial etiology results from blood and tissue samples	During the first 7 days of ICU admission
SAPS II assessment	During the first 24 hours of ICU admission
LRINEC score assessment	During the first 7 days of ICU admission
Number of debridements	During the first 7 days of ICU admission
Vasoactive biomarkers as indicators of treatment effects after HBOT	The first 5 days of admission
Multiple organ failure assessed by the MODS score	During the first 7 days of ICU admission
Amputation rate	During the first 7 days of ICU admission
Anaya score assessment	During the first 7 days of ICU admission

Trial Locations

Locations (1)

Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, Denmark