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

Necrotizing Soft Tissue Infection Clinical Trial

— BIONEC-II  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501382
• Other study ID #: BIONEC2-MBH-2015
• Status: Completed
• Start date: February 2013
• Est. completion date: December 1, 2015

Study information

• Verified date: June 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 1, 2015
• Est. primary completion date: December 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Fasciitis
• Fasciitis, Necrotizing
• Fournier Gangrene
• Gangrene
• Gas Gangrene
• Infection
• Necrotizing Fasciitis
• Necrotizing Soft Tissue Infection
• Soft Tissue Infections

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Ole Hyldegaard

Country where clinical trial is conducted

Denmark, 

Outcome

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