ACTRN12617000783325已完成2 期
Restoration Of gut miCroflora in CrITical Illness (The ROCIT trial): A multicentre Randomised controlled trial of probiotic therapy to reduce nosocomial infection and increase days alive and out of hospital in critically ill patients admitted to the intensive care unit.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •* Admitted to the ICU or high dependency area for less than 48 hours
- •* Anticipated to require intensive care or high dependency area care beyond the next calendar day
排除标准
- •1. less than 18 years of age
- •2. Absolute contraindication to receiving medication via the enteral route
- •3. Known to be receiving probiotic therapy at time of index hospitalisation
- •4. Acute pancreatitis as a cause or complication of current admission
- •5. Immunosuppressed, e.g. chemotherapy within four weeks of admission, receiving greater than or equal to 1.5mg/kg methylprednisolone daily or equivalent for more than four days
- •6. Neutropenia (neutrophil count less than 1x109/L)
- •7. Prosthetic heart valve or permanent pace maker
- •8. Death is deemed to be inevitable as a result of the current acute illness AND either the treating clinician, the patient, or the substitute decision maker are not committed to full active treatment
- •9. Enrolment not considered in the patient’s best interest
- •10. Previously enrolled in the ROCIT study
- •11. Unlikely to be residing in the Perth Metropolitan area in 60 days time
- •12. Participating in a competing interventional study
- •13. Pregnancy
- •14. Admitted to hospital from a high level nursing facility or rehabilitation facility
研究者
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