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临床试验/NCT07120581
NCT07120581进行中(未招募)不适用

Hyperbaric Oxygen Therapy as Salvage Therapy for Healthy, Severely Injured, Mechanically Ventilated Invasive Fungal Infection Cases Resistant to Therapy

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2024年8月4日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
7
试验地点
1
主要终点
Eradication of Fungal Infectious Agent

研究概览

简要总结

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?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients who did not recieve hyperbaric oxygen therapy as part of the treatment
  • Patients with immunosuppression background

结局指标

主要结局

Eradication of Fungal Infectious Agent

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Reudor Grinberg

Intensive Care Physician

Assaf-Harofeh Medical Center

研究点 (1)

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