ACTRN12616001285448已完成2 期
A multi-centre, phase II, randomized, open label, clinical trial comparing combined prophylactic intravenous paracetamol and early targeted physical cooling for fever with standard temperature management in mechanically ventilated adults without acute brain pathologies who are expected to be ventilated beyond the day after randomisation.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 184
研究概览
简要总结
Active temperature management reduced body temperature compared with usual care; however, fever abated rapidly, even in patients assigned to usual care, and the magnitude of temperature separation was small. Our findings do not provide strong support for a larger clinical trial using this design in this patient population. However they do provide preliminary data supporting the safety of regular administration of intravenous paracetamol in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •1. Patients requiring invasive mechanical ventilation in the ICU and expected to be receiving mechanical ventilation beyond the day after randomisation.
- •2. Fever (body temperature 37.8 degrees Celsius or more) in the previous 12 hours.
- •3. Deeply sedated with no response to voice
排除标准
- •1. Acute brain pathologies (traumatic brain injury, intracerebral haemorrhage, subarachnoid haemorrhage, or ischaemic stroke).
- •2. Confirmed or suspected hypoxic ischaemic encephalopathy (includes all patients who have had a recent cardiac arrest where there is clinical concern about possible brain damage as a result of the cardiac arrest).
- •3. 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.
- •4. Patients admitted to the intensive care unit with greater than or equal to 20% total body surface area burns.
- •5. Life expectancy of less than 90 days due to an underlying medical condition.
- •6 Fulfilled all other eligibility criteria >24 hours ago but was not enrolled in the study.
- •7. Previously enrolled in the REACTOR study.
研究者
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