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Trial record 2 of 4 for:    hyperbaric AND necrotizing AND infection

Modulation of Biomarkers in Patients With Flesh-eating Bacterial Infections After With Hyperbaric Oxygen Treatment (BIONEC-II)

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ClinicalTrials.gov Identifier: NCT02501382
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Ole Hyldegaard, Rigshospitalet, Denmark

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

Condition or disease
Necrotizing Soft Tissue Infection Necrotizing Fasciitis Gas Gangrene Fournier Gangrene

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.


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Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers in Necrotizing Soft Tissue Infections - Effects of Hyperbaric Oxygen Treatment on the Immune Response
Actual Study Start Date : February 2013
Actual Primary Completion Date : December 1, 2015
Actual Study Completion Date : December 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Group/Cohort
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Inflammatory biomarkers as indicators of treatment effects after HBOT [ Time Frame: The first 5 days of admission ]
  2. Vasoactive biomarkers as indicators of treatment effects after HBOT [ Time Frame: The first 5 days of admission ]
  3. Mortality [ Time Frame: 30, 90, 180 days ]
  4. Amputation rate [ Time Frame: During the first 7 days of ICU admission ]
  5. SAPS II assessment [ Time Frame: During the first 24 hours of ICU admission ]
  6. APACHE II assessment [ Time Frame: During the first 7 days of ICU admission ]
  7. SOFA score assessment [ Time Frame: During the first 7 days of ICU admission ]
  8. Anaya score assessment [ Time Frame: During the first 7 days of ICU admission ]
  9. LRINEC score assessment [ Time Frame: During the first 7 days of ICU admission ]
  10. Multiple organ failure assessed by the MODS score [ Time Frame: During the first 7 days of ICU admission ]
  11. Number of debridements [ Time Frame: During the first 7 days of ICU admission ]
  12. Microbial etiology results from blood and tissue samples [ Time Frame: During the first 7 days of ICU admission ]

Biospecimen Retention:   Samples Without DNA
Whole blood and plasma/serum


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with NSTI treated with HBOT
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501382


Locations
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Denmark
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Ole Hyldegaard
Investigators
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Study Director: Ole Hyldegaard, MD, PhD Department of Anaesthesiology, Center of Hyperbaric Treatment, sect. 4092, Copenhagen University Hospital, Denmark
Principal Investigator: Marco Bo Hansen, MD Department of Anaesthesiology, Center of Hyperbaric Treatment, sect. 4092, Copenhagen University Hospital, Denmark

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Responsible Party: Ole Hyldegaard, MD, PhD, DMSci, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02501382     History of Changes
Other Study ID Numbers: BIONEC2-MBH-2015
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019

Keywords provided by Ole Hyldegaard, Rigshospitalet, Denmark:
Fasciitis
Fasciitis, Necrotizing
Soft tissue infections
Fournier's gangrene
Immunopathogenesis

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Soft Tissue Infections
Fasciitis, Necrotizing
Bacterial Infections
Clostridium Infections
Gram-Positive Bacterial Infections
Fournier Gangrene
Gas Gangrene
Fasciitis
Gangrene
Musculoskeletal Diseases
Necrosis
Pathologic Processes
Skin Diseases, Bacterial
Genital Diseases, Male