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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

Tracking Information
First Submitted Date July 3, 2015
First Posted Date July 17, 2015
Last Update Posted Date June 24, 2019
Actual Study Start Date February 2013
Actual Primary Completion Date December 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 15, 2015)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02501382 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 15, 2015)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood and plasma/serum
Sampling Method Probability Sample
Study Population Patients with NSTI treated with HBOT
Condition
  • Necrotizing Soft Tissue Infection
  • Necrotizing Fasciitis
  • Gas Gangrene
  • Fournier Gangrene
Intervention Not Provided
Study Groups/Cohorts 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 20, 2019)
65
Original Estimated Enrollment
 (submitted: July 15, 2015)
112
Actual Study Completion Date December 1, 2015
Actual Primary Completion Date December 1, 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT02501382
Other Study ID Numbers BIONEC2-MBH-2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ole Hyldegaard, Rigshospitalet, Denmark
Study Sponsor Ole Hyldegaard
Collaborators Not Provided
Investigators
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
PRS Account Rigshospitalet, Denmark
Verification Date June 2019