Individualised Blood Pressure Targets Versus Standard Care Among Critically Ill Patients With Shock - A Multicentre Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,260
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
Aim The aim of the proposed RCT is to determine effectiveness of a strategy, where MAP (mean arterial blood pressure) targets during vasopressor therapy for shock in ICU are individualized based on patients' own pre-illness MAP that would be derived as an average of up to five most recent pre-illness blood pressure readings.
Hypothesis We hypothesize that targeting a patient's pre-illness MAP during management of shock can minimize the degree of MAP-deficit (a measure of relative hypotension), which may help reduce the risk of 14-day mortality and major adverse kidney events by day 14 in ICU.
Endpoints The primary endpoint will be the all-cause mortality rate at day 14. Secondary endpoints will be the time to death through day 14 and day 90, major adverse kidney events (MAKE-14), renal replacement therapy (RRT) free days until day 28, and 90-day all-cause mortality.
Significance To date no major RCT has tested this strategy among ICU patients with shock. This pivotal trial will provide evidence to fulfil a crucial knowledge gap regarding a common and a fundamental intervention in critical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICU patients aged greater than or equal to 40 years
- •The patient is deemed to be in shock, defined as clinician-initiated vasopressor/inotropic therapy AND supported by any of the following within the last 24 hours:
- •Lactate level greater than or equal to 2 mmol/l or base deficit greater than or equal to 3 mmol/l,
- •Urine output less than or equal to 0.5 ml/kg/h or <40 ml/h for 2 or more consecutive hours
- •Respiratory rate >22 per minute
- •Altered mentation (Glasgow Coma Score <14)
排除标准
- •Patients who are moribund, or have documented not-for-resuscitation orders
- •At least 24 hours have lapsed from the time of initiation of vasopressor or inotropic support
- •Patients who are either receiving or are deemed to imminently need renal replacement therapy.
- •Patients who already have an increase in serum creatinine of >350 µmol/l from baseline.
- •End stage renal disease
- •Patients where trauma is the main reason for the current ICU admission.
- •Previously enrolled in the REACT Shock RCT
- •Pregnancy, if known
- •Active bleeding (clinical suspicion or >2 packed red blood cells within last 24 hours)
- •Insufficient (less than two) pre-illness BP readings are available.
- •Patients on extracorporeal support (such as extracorporeal membrane oxygenation, intra-aortic balloon pump, or ventricular assist device).
- •Potential contraindications to either higher or lower BP targets (including but not limited to)
- •Cerebral perfusion pressure guided therapy e.g. intracranial hemorrhage or subarachnoid hemorrhage or traumatic brain injury
- •Abdominal perfusion pressure guided therapy
- •Aortic injury (e.g. dissection or post-operative)
- •Post cardiac surgery
- •Any other condition requiring higher or lower BP target specifically
结局指标
主要结局
Mortality
时间窗: 14 days
All deaths from randomisation to 14 days
次要结局
- Time to death through day 14(First 14 days of randomisation)
- Major Adverse Kidney Events(14 days from randomisation)
- Renal replacement therapy free days until day 28(28 days from randomisation)
- Peak increase in serum creatinine levels(28 days from randomisation)
- Time to death through day 90(First 90 days of randomisation)
- Mortality(90 days)
研究者
Rakshit Panwar
Conjoint Associate Professor
University of Newcastle, Australia