NCT07120581
Active, not recruiting
Not Applicable
Hyperbaric Oxygen Therapy as Salvage Therapy for Healthy, Severely Injured, Mechanically Ventilated Invasive Fungal Infection Cases Resistant to Therapy
Assaf-Harofeh Medical Center1 site in 1 country7 target enrollmentStarted: August 4, 2024Last updated:
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Eradication of Fungal Infectious Agent
Overview
Brief Summary
The goal of this observational study is to learn about the effects of Hyperbaric Oxygen Therapy on healthy individual who suffer from invasive fungal infection caused by severe trauma, who do not respond to conventional treatment. The main question it aims to answer is:
Does the treatment aid in eradicating the infection and improve the overall outcome of such patients?
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •at least 18 year old
- •Trauma as the insult type causing the infection
- •Refractory IFI with failure to respond to standard therapy (medical and surgical)
- •Hyperbaric Oxygen Therapy as part of the treatment
Exclusion Criteria
- •Patients who did not recieve hyperbaric oxygen therapy as part of the treatment
- •Patients with immunosuppression background
Outcomes
Primary Outcomes
Eradication of Fungal Infectious Agent
Time Frame: From enrollment, baseline day 1, through study completion, an average of 4-8 weeks
The time it takes from the start of treatments and until the first negative culture was found.
Secondary Outcomes
- Clinical Status on Discharge- ventilation status(From enrollment, baseline day 1, through study completion, an average of 4-8 weeks)
- clinical status on discharge- kidney function(From enrollment, baseline day 1, through study completion, an average of 4-8 weeks)
- clinical status on discharge- Kidney function(From enrollment, baseline day 1, through study completion, an average of 4-8 weeks)
- clinical status on discharge- consciousness level(From enrollment, baseline day 1, through study completion, an average of 4-8 weeks)
- clinical status on discharge- wound status(From enrollment, baseline day 1, through study completion, an average of 4-8 weeks)
- clinical status on discharge- location of discharge(From enrollment, baseline day 1, through study completion, an average of 4-8 weeks)
- Adverse Events(From enrollment, baseline day 1, through study completion, an average of 4-8 weeks)
Investigators
Reudor Grinberg
Intensive Care Physician
Assaf-Harofeh Medical Center
Study Sites (1)
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