The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,554
- 试验地点
- 31
- 主要终点
- 90-day Mortality
研究概览
简要总结
The purpose of this trial is to assess patient important benefits and harms of IV fluid restriction vs. standard care fluid therapy in patients with septic shock.
详细描述
BACKGROUND:
Septic shock is common, often lethal, costly, and associated with prolonged suffering among survivors and relatives. Traditionally, intravenous (IV) fluids are used to optimise the circulation, and the use of higher volumes is recommended by international guidelines. There is, however, no high-quality evidence to support this. In contrast, data from cohort studies, small trials and systematic reviews in sepsis and large trials in other settings and patient groups suggest potential benefits from restriction of IV fluids in patients with septic shock.
OBJECTIVES:
The aim of the CLASSIC trial is to assess the benefits and harms of IV fluid restriction vs. standard care on patient-important outcome measures in adult intensive care unit (ICU) patients with septic shock.
DESIGN:
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessor- and analyst-blinded trial
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
- •All the following criteria must be fulfilled:
- •Aged 18 years or above
- •Admitted to the ICU or plan to be admitted to the ICU regardless of trial participation
- •Septic shock defined according to the Sepsis-3 criteria:
- •Suspected or confirmed site of infection or positive blood culture AND
- •Ongoing infusion of vasopressor/inotrope agent to maintain a mean arterial blood pressure of 65 mmHg or above AND
- •Lactate of 2 mmol/L or above in any plasma sample performed within the last 3-hours
- •Have received at least 1 L of IV fluid (crystalloids, colloids or blood products) in the last 24-hours prior to screening.
排除标准
- •Patients who fulfil any of the following criteria will be excluded:
- •Septic shock for more than 12 hours at the time of screening as these patients are no longer early in their course
- •Life-threatening bleeding as these patients need specific fluid/blood product strategies
- •Acute burn injury of more than 10% of the body surface area as these patients need a specific fluid strategy
- •Known pregnancy
- •Consent not obtainable as per the model approved for the specific site
研究组 & 干预措施
Fluid restriction group
No IV fluids unless one of the extenuating circumstances occur; then, IV fluid may be given in measured amounts:
- In case of severe hypoperfusion or severe circulatory impairment defined by either:
- Lactate≥4 mmol/L
- MAP<50 mmHg (with or without vasopressor/inotrope)
- Mottling beyond the kneecap (mottling score >2) OR
- Urinary output<0.1 mL/kg bodyweight/h, but only in the first 2hrs after randomisation
A bolus of 250-500 ml of IV crystalloid solution may be given followed by re-evaluation 2. In case of overt fluid losses (e.g. vomiting, large aspirates,...) IV fluid may be given to correct for the loss, but not above the volume lost. 3. In case the oral/enteral route for water or electrolyte solutions is contraindicated or has failed, IV fluids may be given to:
- Correct dehydration or electrolyte deficiencies
- Ensure a total fluid input of 1L per 24hrs
IV fluids may be given as carrier for medication, but the volume should be reduced to the lowest possible
干预措施: Isotonic crystalloids (Drug)
Standard-care
There will be no upper limit for the use of either IV or oral/enteral fluids. In particular:
- IV fluids should be given in the case of hypoperfusion or circulatory impairment and should be continued as long as hemodynamic variables improve including static or dynamic variable(s) as chosen by the clinicians. These criteria are based on the Surviving Sepsis Campaign guideline.
- IV fluids should be given as maintenance if the ICU has a protocol recommending maintenance fluid
- IV fluids should be given to substitute expected or observed loss, dehydration or electrolyte derangements
干预措施: Isotonic crystalloids (Drug)
结局指标
主要结局
90-day Mortality
时间窗: Day 90 after randomisation
Al cause mortality at 90 days
次要结局
- Number of Participants With One or More Serious Adverse Events (SAEs) in the ICU(Until ICU discharge, maximum 90 days)
- Number of Participants With One or More Serious Adverse Reactions (SARs) to IV Crystalloids in the ICU.(Until ICU discharge, maximum 90 days)
- Days Alive at Day 90 Without Life Support (Vasopressor / Inotropic Support, Invasive Mechanical Ventilation or Renal Replacement Therapy)(Until ICU discharge, maximum 90 days)
- Days Alive and Out of Hospital at Day 90(Day 90 after randomisation)
- All-cause Mortality at 1-year After Randomisation(1-year after randomisation)
- Health-related Quality of Life 1 Year After Randomisation(1 year after randomisation)
- Cognitive Function 1-year After Randomisation(1-year after randomisation)
研究者
Anders Perner, MD, PhD
MD, PhD, Senior staff specialist , Professor in Intensive Care
Scandinavian Critical Care Trials Group