NCT03680963已完成不适用
Early Versus Differed Arterial Catheterization in Critically Ill Patients With Acute Circulatory Failure: A Multicentre, Open-label, Pragmatic, Randomised, Non-inferiority Controlled Trial (EVERDAC Trial)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,010
- 试验地点
- 10
- 主要终点
- All-cause mortality by 28 days after randomisation
研究概览
简要总结
The objective of the present research is a combination of a one-sided test of non-inferiority and a one-sided test of superiority. A stepped approach will be used to evaluate these hypotheses:
- a less invasive intervention (i.e., no indwelling arterial catheter insertion until felt absolutely needed, according to consensual and predefined safety criteria) is non inferior to usual care (i.e., systematic indwelling arterial catheter insertion in the early hours of shock) in terms of mortality at day 28 (non-inferiority margin of 5%).
- a less invasive intervention is not only non-inferior but also superior to usual care in terms of mortality.
Multi-centre, pragmatic, randomised, controlled, open, two-parallel group, non-inferiority clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years the day of inclusion
- •Existence of an acute circulatory failure defined by the presence of the following items 1 and 2:
- •Persisting hypotension (systolic blood pressure less than 90 mmHg or mean arterial blood pressure less than 65 mmHg) for more than 15 min at intensive care unit admission or within the following 24 hours, OR requirement of continuous intravenous vasopressor treatment (i.e. any dose of norepinephrine / epinephrine)
- •Presence at least one of the following signs of hypoperfusion: alteration of mental status; skin mottling; oliguria defined as a urine output < 0.5 mL/kg body weight for at least one hour; arterial lactate > 2 mmol/L; peripheral venous lactate > 3.2 mmol/L; ScvO2 <70%
- •Free express oral and informed consent of the patient or a proxy in case of impossibility for the patient to consent; emergency inclusion possible when legal representatives and patient's family are not available
- •French health insurance holder
排除标准
- •Acute circulatory failure, as defined by items 1 and 2 in inclusion criteria list (cf. supra) present for more than 24 hours
- •Non invasive blood pressure (NIBP) device fails to display a blood pressure value, or cuff placement impossible
- •Patient for whom an Extra-Corporeal Membrane Oxygenation (ECMO) therapy (either veno-arterial or venous-venous) is already in place or is to be initiated within the next 6 hours
- •Patient treated with vasopressor doses of more than 2.5 μg/kg/min of norepinephrine tartrate plus epinephrine for at least 2 hours (i.e., for instance, more than 8 mg of norepinephrine tartrate in 50 mL at the rate of 66 mL/hour for a patient weighing 70 kg) (please note that in fact this dosage corresponds to 1.25 μg/kg/min of norepinephrine base)
- •Severe traumatic brain injury (i.e., traumatic brain injury with a Glasgow coma scale score of less than 9 before sedation)
- •Patient previously included in the trial
- •Body mass index (BMI) above 40 kg/m2
- •Pregnancy
- •Brain death
- •Moribund patient
- •Patient known, at time of inclusion, as being under guardianship, authorship or curators
研究组 & 干预措施
Non-invasive strategy
Experimental
Non-invasive strategy consisting of blood pressure monitoring by non-invasive automated cuff measurements
干预措施: Non-invasive strategy (Procedure)
Control strategy
Other
Usual strategy of systematic indwelling arterial catheter insertion in the early hours of acute circulatory failure
干预措施: Control strategy (Procedure)
结局指标
主要结局
All-cause mortality by 28 days after randomisation
时间窗: Patients will be followed from randomization to day 28
次要结局
- Cumulative incidence of death(From inclusion through Day 90)
- Cumulative survival free of indwelling arterial catheter insertion(From inclusion through Day 90)
- Number of patients who underwent indwelling arterial catheter insertion, in both groups(From randomization to Day 28)
- Mean daily blood volume drawn for lab testing during intensive care unit stay(From inclusion to Day 28)
- Number of blood cultures performed during intensive care unit stay(From inclusion to Day 28)
- Number of bloodstream infections(During intensive care unit stay)
- Number of attempts at arterial puncture during intensive care unit stay(From inclusion to Day 28)
- Evolution of blood haemoglobin level(From Day 1 to Day 28)
- Duration of intensive care unit stay(From inclusion to discharge)
- Evolution of haematocrit(From Day 1 to Day 28)
- Number of red blood cell packs transfused(From Day 1 to Day 28)
- Number of transcutaneous arterial and venous puncture for lab tests, arterial catheter insertion and set up of monitor, blood drawing from the arterial catheter or other vascular line(From inclusion to Day 28)
- Time (min) spent by nurses and physicians (min) on these tasks(During the first three days of the intensive care unit stay)
- Number of arterial and central venous catheter insertion during intensive care unit stay(From inclusion to Day 28)
- Numbers of arterial and central venous catheter-related infections(During intensive care unit stay)
- Numbers of local infections of arterial and central venous(During intensive care unit stay)
- Numbers of arterial and central venous catheter-related bloodstream infections(During intensive care unit stay)
- Duration of hospital stay(From inclusion to discharge)
- Intensive care unit mortality(From inclusion to discharge)
- Hospital mortality(From inclusion to discharge)
- Day 90 mortality(Day 90)
- Number of Adverse Events of special interest(From inclusion to Day 90)
- Incremental Cost-Effectiveness Ratio(At Day 28)
- To account for the potential bias brought by deaths occurring as the result of life-sustaining treatments withdrawal/withholding, as frequently encountered in intensive care unit, the investigators will record such events(From inclusion to Day 35)
- Evolution of daily Sequential Organ Failure Assessment (SOFA) score(During the first seven days)
- Daily amount of intravenous fluid given for rapid vascular volume expansion(From Day 1 to Day 7)
- Duration of mechanical ventilation(From inclusion to Day 28)
- Ventilator-free days(From Day 1 to Day 28)
- Proportion of patients treated by renal-replacement therapy(Between Day 1 and Day 28)
- Renal replacement therapy-free days(From Day 1 to Day 28)
- Proportion of patients treated by vasopressor(Between Day 1 and Day 28)
- Vasopressor therapy-free days(From Day 1 to Day 28)
- Budget impact analysis of the generalization of the non-invasive strategy(on a 5 years' time frame)
- Pain related to the device used for blood pressure monitoring(Once a day, from inclusion to Day 28)
- Discomfort related to device used for blood pressure monitoring(One a day, from inclusion to Day 28)
- Daily fluid balance of intakes and loss(The first seven days)
研究者
研究点 (10)
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