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

• ClinicalTrials.gov Identifier: NCT02501382
• Recruitment Status: Completed
• First Posted: July 17, 2015
• Last Update Posted: June 24, 2019
• Sponsor: Ole Hyldegaard
• 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

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

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