Multicentre, Unblinded, Open Label, Randomised, Controlled Trial to Assess the Effect of Augmented Vs. Normal Continuous Renal Replacement Therapy (CRRT) on 90-Day All-Cause Mortality of Intensive Care Unit Patients With Severe Acute Renal Failure (ARF).
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,508
- 试验地点
- 2
- 主要终点
- Death from all causes at 90 days after randomisation.
研究概览
简要总结
This study seeks to determine if increasing the dose of continuous renal replacement therapy (CRRT) reduces 90-day all cause mortality in Intensive Care Unit (ICU) patients with severe acute renal failure (ARF).
详细描述
Study Title - Multicentre, Unblinded, Randomised, Controlled Trial to assess the effect of Augmented vs. Normal Continuous Renal Replacement Therapy (CRRT) on 90-day all-cause mortality of Intensive Care Unit Patients with Severe Acute Renal Failure (ARF).
Clinical Phase - IV
Study Rationale - This study will provide high quality evidence from a mulit-center randomised controlled trial about the comparative effects of different targets for CRRT dose in patients with ARF treated in the Australasian intensive care setting. This evidence will have direct relevance to decisions about the care of critically ill patients admitted to intensive care units in Australia and New Zealand. If this study confirms the treatment effect reported in the Lancet study, augmented dose CRRT is likely too become the standard of treatment, saving 250-300 lives/year in Australia and 15,000 lives/year worldwide.
Trial Design - The proposed study will compare an "augmented" CRRT regimen to deliver an effluent rate of 40 ml/kg/hr compared to "normal" CRRT at an effluent rate of 25ml/kg/hr in ICU patients with severe ARF.
Subject Participation - 90 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The treating clinician believes that the patient requires CRRT for acute renal failure.
- •The clinician is uncertain about the balance of benefits and risks likely to be conferred by treatment with higher intensity or lower intensity CRRT.
- •The treating clinicians anticipate treating the patient with CRRT for at least 72 hours.
- •Informed consent has been obtained
- •The patient fulfils ONE of the following clinical criteria for initiating CRRT:
- •Oliguria (urine output < 100ml/6hr) that has been unresponsive to fluid resuscitation measures.
- •Hyperkalemia ([K+] > 6.5 mmol/L).
- •Severe acidemia (pH < 7.2).
- •Urea > 25 mmol/liter.
- •Creatinine >300 micromol/L in the setting of ARF.
- •Clinically significant organ oedema in the setting of ARF (eg: lung).
排除标准
- •Patient age is <18 years.
- •Death is imminent (<24 hours).
- •There is a strong likelihood that the study treatment would not be continued in accordance with the study protocol.
- •The patient has been treated with CRRT or other dialysis previously during the same hospital admission.
- •The patient was on maintenance dialysis prior to the current hospitalisation.
- •The patient's body weight is <60 kg or >100kg.
- •Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
结局指标
主要结局
Death from all causes at 90 days after randomisation.
时间窗: Within 90 days after randomisation
次要结局
- Death prior to hospital discharge.(0 to 90 days)
- Length of ICU stay.(0 to 90 days)
- Dialysis-independent survival.(0 to 90 days)
- Death within the in the intensive care unit.(0 to 90 days)
- CRRT-free days.(0 to 90 days)
- Death within 28 days of randomisation.(Within 28 days of randomisation.)
- Length of hospital stay.(0 to 90 days)
- The need for and duration of other organ support (inotropic/vasopressor support and positive pressure ventilation).(0 to 90 days)