Hyperbaric Oxygen Therapy, Invasive Fungal Infections
Conditions
Keywords
Hyperbaric Oxygen Therapy, Invasive Fungal Infection, Trauma
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?
Interventions
OTHERHyperbaric Oxygen Therapy
Hyperbaric Oxygen Therapy at increasing pressure to 2.8 ATA for 2 hours sessions. Breaks of 5 every 20 minutes from the oxygen to air to avoid hyperoxia. Continued for the duration of the hospitalization in the ICU on a daily basis.
Sponsors
Assaf-Harofeh Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication of Fungal Infectious Agent | 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
| Measure | Time frame | Description |
|---|---|---|
| clinical status on discharge- kidney function | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks | the patient's kidney function assessed by presence of elevated Creatinine levels at discharge (mg\\dl) |
| clinical status on discharge- Kidney function | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks | The patient's kidney function assessed by need for dialysis (yes/no) |
| clinical status on discharge- consciousness level | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks | evaluation of the patient's consciousness level as either alert and responsive or still requiring sedation |
| Clinical Status on Discharge- ventilation status | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks | what support is the patient receiving upon discharge in terms of ventilation including invasive or non-invasive ventilation, need for oxygen or room-air |
| clinical status on discharge- location of discharge | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks | where were the patients discharged to- regular inpatient ward, a different medical center and which department (ICU or regular inpatient), rehabilitation center or not discharged (in case of death during the hospitalization). |
| Adverse Events | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks | description of comlications occuring during the treatment, most notably seizures during the hyperbaric oxygen treatments |
| clinical status on discharge- wound status | From enrollment, baseline day 1, through study completion, an average of 4-8 weeks | Whether the patient recieved a successful skin graft |
Countries
Israel
Outcome results
None listed