Role of Active Deresuscitation After Resuscitation- 2: a Pilot Randomised Controlled Trial of Conservative Fluid Management Versus Usual Care in Critical Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 8
- 主要终点
- Day 3 fluid balance
研究概览
简要总结
RADAR-2 will be a randomised, open-label, allocation concealed, pilot trial of conservative fluid administration and deresuscitation compared with usual care in patients who are critically ill.
详细描述
The optimal approach to fluid balance in critically ill patients is uncertain. A recent systematic review found low quality evidence in favour of a conservative fluid or deresuscitative approach (active removal of accumulated fluid using diuretics and/or renal replacement therapy) compared with a liberal strategy or usual care. The RADAR-2 pilot randomised trial will compare conservative fluid and deresuscitation with usual care in patients who are mechanically ventilated in an intensive care unit. The main hypothesis is that in critically ill patients, a post-resuscitation fluid strategy comprising conservative fluid administration and active deresuscitation reduces net fluid balance, is safe and improves clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Group assignment and early (up to 28 day) data will be locked and unavailable to investigators undertaking 6-month follow up.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Invasive mechanical ventilation
- •Treating ICU doctor expects patient to require treatment in an ICU beyond the next calendar day
- •Between 24 and 48 hours from ICU admission at the time of randomisation
排除标准
- •Age < 16 years
- •Body weight <40kg (measured or estimated)
- •Diabetic ketoacidosis or Hyperosmolar hyperglycaemic state
- •Non-traumatic subarachnoid haemorrhage
- •Acute cardiac failure or cardiogenic shock
- •End-stage renal failure (on dialysis)
- •Known to be pregnant
- •Suspected or proven active diabetes insipidus (DDAVP within 24 hours)
- •Not expected to survive for 72 hours
- •Active 'Do not attempt resuscitation' order
- •Refusal of consent
- •Inability of personal consultee to understand written or verbal information and for whom no interpreter is available
- •Known allergy to one or more of the study drugs
- •Inability to measure fluid balance
研究组 & 干预措施
Conservative fluid and deresuscitation
- Fluid restriction (avoidance of maintenance intravenous fluid and minimisation of drug diluent volumes)
- Daily assessment of eligibility for deresuscitation for 3 days (eligible if oedema in more than 1 site and cumulative fluid balance > 2 litres)
- Deresuscitation to target negative daily fluid balance of 1 to 3 litres:
5mg Indapamide daily (enteral) 100mg Spironolactone daily (enteral) 0.5mg/kg furosemide once (intravenous, max 40mg) 2.5-20mg/hr furosemide infusion titrated to effect OR continuous renal replacement therapy with fluid removal
干预措施: Conservative fluid and deresuscitation strategy (Other)
Usual care
Usual care at the discretion of the treating team
干预措施: Usual care strategy (Other)
结局指标
主要结局
Day 3 fluid balance
时间窗: From beginning of day 2 to the beginning of study day 3.
Change in fluid balance (mL) between the beginning of study day 2 and the beginning of study day 3.
次要结局
- Incidence of reported adverse events(Up to study day 5)
- Mortality(28 and 180 days)
- Length of ICU stay(28 days)
- Acute kidney injury(Up to day 5.)
- Cumulative fluid balance(Up to the beginning of days 3 and 5, and at ICU discharge (estimated median day 7))
- Incidence of significant protocol violations(Up to study day 5)
- Change in Sequential Organ Function Assessment scores(From baseline until day 3 and day 5)
- Cognitive function(180 days)
- Duration of mechanical ventilation(28 days)
- Health-related quality of life(180 days)