Clinical trial NCT02501382: Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment
Official title: Biomarkers in Necrotizing Soft Tissue Infections - Effects of Hyperbaric Oxygen Treatment on the Immune Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Necrotizing Soft Tissue Infection
Necrotizing Fasciitis
Gas Gangrene
Fournier Gangrene
Keywords: Fasciitis
Fasciitis, Necrotizing
Soft tissue infections
Fournier's gangrene
Immunopathogenesis
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2015-07-17
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with NSTI treated with HBOT

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.

Eligibility criteria: 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

Primary outcomes:
measure: IL-6 as a marker of treatment effects after HBOT
timeFrame: Change from baseline in IL-6 concentration after first HBOT administered during the first 24 hours of admission
Secondary outcomes:
measure: Inflammatory biomarkers as indicators of treatment effects after HBOT
timeFrame: The first 5 days of admission
measure: Vasoactive biomarkers as indicators of treatment effects after HBOT
timeFrame: The first 5 days of admission
measure: Mortality
timeFrame: 30, 90, 180 days
measure: Amputation rate
timeFrame: During the first 7 days of ICU admission
measure: SAPS II assessment
timeFrame: During the first 24 hours of ICU admission
measure: APACHE II assessment
timeFrame: During the first 7 days of ICU admission
measure: SOFA score assessment
timeFrame: During the first 7 days of ICU admission
measure: Anaya score assessment
timeFrame: During the first 7 days of ICU admission
measure: LRINEC score assessment
timeFrame: During the first 7 days of ICU admission
measure: Multiple organ failure assessed by the MODS score
timeFrame: During the first 7 days of ICU admission
measure: Number of debridements
timeFrame: During the first 7 days of ICU admission
measure: Microbial etiology results from blood and tissue samples
timeFrame: During the first 7 days of ICU admission
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Department of Anaesthesiology, Center of Hyperbaric Treatment, sect. 4092, Copenhagen University Hospital, Denmark
name: Ole Hyldegaard, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Anaesthesiology, Center of Hyperbaric Treatment, sect. 4092, Copenhagen University Hospital, Denmark
name: Marco Bo Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: