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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02501382
Other study ID # BIONEC2-MBH-2015
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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