Necrotizing Soft Tissue InfectionBIONEC-IINCT02501382
Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment
An observational study of Necrotizing Soft Tissue Infection and Necrotizing Fasciitis, run by Ole Hyldegaard at 1 site in Denmark.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Soft Tissue Infection, Necrotizing Fasciitis, Gas Gangrene
- How many people
- 65 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to 1 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with NSTI treated with HBOT
Who may be able to join
- 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
Who cannot join
- Patients who at the operating theatre were categorized as a non-NSTI patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Keywords
- Fasciitis, Fasciitis, Necrotizing, Soft tissue infections, Fournier's gangrene, Immunopathogenesis
- Medical subject headings
- Fasciitis, Necrotizing, Gas Gangrene, Fournier Gangrene, Fasciitis, Soft Tissue Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
IL-6 as a marker of treatment effects after HBOT
Measured: Change from baseline in IL-6 concentration after first HBOT administered during the first 24 hours of admission
Secondary outcomes (12)
Inflammatory biomarkers as indicators of treatment effects after HBOT
Measured: The first 5 days of admission
Vasoactive biomarkers as indicators of treatment effects after HBOT
Measured: The first 5 days of admission
Mortality
Measured: 30, 90, 180 days
Amputation rate
Measured: During the first 7 days of ICU admission
SAPS II assessment
Measured: During the first 24 hours of ICU admission
APACHE II assessment
Measured: During the first 7 days of ICU admission
SOFA score assessment
Measured: During the first 7 days of ICU admission
Anaya score assessment
Measured: During the first 7 days of ICU admission
LRINEC score assessment
Measured: During the first 7 days of ICU admission
Multiple organ failure assessed by the MODS score
Measured: During the first 7 days of ICU admission
Number of debridements
Measured: During the first 7 days of ICU admission
Microbial etiology results from blood and tissue samples
Measured: During the first 7 days of ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startFeb 2013
- Primary completion1 Dec 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Soft Tissue InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ole Hyldegaard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ole Hyldegaard, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Ole Hyldegaard, MD, PhD, Study director, Department of Anaesthesiology, Center of Hyperbaric Treatment, sect. 4092, Copenhagen University Hospital, DenmarkMarco Bo Hansen, MD, Principal investigator, Department of Anaesthesiology, Center of Hyperbaric Treatment, sect. 4092, Copenhagen University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501382
- Sponsor's protocol ID
- BIONEC2-MBH-2015
- Acronym
- BIONEC-II
- Status last verified
- Jun 2019
- First submitted
- 3 Jul 2015
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Necrotizing Soft Tissue Infections - Effects of Hyperbaric Oxygen Treatment on the Immune Response
- ClinicalTrials.gov ID
- NCT02501382
- Acronym / sponsor ID
- BIONEC-II / BIONEC2-MBH-2015
- Keywords
- Fasciitis, Fasciitis, Necrotizing, Soft tissue infections, Fournier's gangrene, Immunopathogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ole HyldegaardUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- 1 Dec 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with NSTI treated with HBOT
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who at the operating theatre were categorized as a non-NSTI patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
IL-6 as a marker of treatment effects after HBOT
Time frame: Change from baseline in IL-6 concentration after first HBOT administered during the first 24 hours of admission
12 secondary outcomes
Inflammatory biomarkers as indicators of treatment effects after HBOT
Time frame: The first 5 days of admission
Vasoactive biomarkers as indicators of treatment effects after HBOT
Time frame: The first 5 days of admission
Mortality
Time frame: 30, 90, 180 days
Amputation rate
Time frame: During the first 7 days of ICU admission
SAPS II assessment
Time frame: During the first 24 hours of ICU admission
APACHE II assessment
Time frame: During the first 7 days of ICU admission
SOFA score assessment
Time frame: During the first 7 days of ICU admission
Anaya score assessment
Time frame: During the first 7 days of ICU admission
LRINEC score assessment
Time frame: During the first 7 days of ICU admission
Multiple organ failure assessed by the MODS score
Time frame: During the first 7 days of ICU admission
Number of debridements
Time frame: During the first 7 days of ICU admission
Microbial etiology results from blood and tissue samples
Time frame: During the first 7 days of ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Hyldegaard, MD, PhD study director
Department of Anaesthesiology, Center of Hyperbaric Treatment, sect. 4092, Copenhagen University Hospital, Denmark
Marco Bo Hansen, MD principal investigator
Department of Anaesthesiology, Center of Hyperbaric Treatment, sect. 4092, Copenhagen University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Soft Tissue Infection and Necrotizing Fasciitis, run by Ole Hyldegaard at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-6 as a marker of treatment effects after HBOT (time frame: Change from baseline in IL-6 concentration after first HBOT administered during the first 24 hours of admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2019.