NCT02476253已完成3 期
Sodium Bicarbonate to Treat Severe Acidosis in the Critically Ill : A Multiple Center Randomized Clinical Trial (BICAR-ICU)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4
研究概览
简要总结
The purpose of the present study is to compare the adjunct treatment of metabolic or mixed severe acidosis in the critically ill using Sodium Bicarbonate as a buffer to increase the plasma pH vs no buffering therapy.
The study is a randomized multiple center clinical trial with the outcome as a primary endpoint.
详细描述
- Design: randomized multiple center clinical trial, open label
- Arms: intravenous 4.2% Sodium Bicarbonate vs no additional treatment
- Inclusion: age of 18 yo or above, critically ill patient with a SOFA score of 4 or above, lactatemia of 2mmol/l or above, with pH of 7.20 or below and PaCO2 of 45mmHg or below and bicarbonatemia of 20mmol/l or below
- Exclusion: single respiratory disorder (PaCO2 > 50 mmHg, Bicarbonatemia equal or higher than (PaCO2-40)/10 + 24 ; acute diarrhea, ileostomy or biliary drainage ; stage IV kidney failure or chronic dialysis ; tubular acidosis, ketoacidosis, high anion gap acids poisoning (PEG, aspirin, methanol) ; PaCO2 equal to 45mmHg or above and spontaneous breathing, pregnancy, protected patients, moribund patient (life expectancy of 48h or below)
- Randomization: website randomization with stratification on age, presence of sepsis at inclusion, renal failure
- Intervention: experimental arm: intravenous 4.2% Sodium Bicarbonate 125 to 250ml in 30min up to 1000ml/24h. The target is a plasma pH of 7.30 or above.
- An interim statistical analysis is planned when 200 patients will be included
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
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
- •Age of 18 yo or above,
- •Critically ill patient with a SOFA score of 4 or above,
- •Lactatemia of 2mmol/l or above, with pH of 7.20 or below and PaCO2 of 45mmHg or below and bicarbonatemia of 20mmol/l or below
排除标准
- •Administration of Sodium Bicarbonate 24 hours before inclusion
- •Single respiratory disorder (PaCO2 > 50 mmHg, Bicarbonatemia equal or higher than (PaCO2-40)/10 + 24
- •Acute diarrhea, ileostomy or biliary drainage
- •Stage IV kidney failure or chronic dialysis
- •Tubular acidosis, ketoacidosis, high anion gap acids poisoning (PEG, aspirin, methanol)
- •PaCO2 equal to 45mmHg or above and spontaneous breathing, pregnancy, protected patients, moribund patient (life expectancy of 48h or below)
研究组 & 干预措施
Intervention
Experimental
Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30
干预措施: Sodium Bicarbonate (Drug)
结局指标
主要结局
Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4
时间窗: Day 0 to Day 28
Composite criteria of Day 28 mortality and/or patients with at least one organ failure defined as a SOFA score of 3 or 4
次要结局
- Evolution of the organ failure scores(Day 0 to Day 28)
- Duration of mechanical ventilation and ventilatory free days (days)(Day 0 to Day 28)
- Duration of vasopressors administration (h)(Day 0 to Day 28)
- Duration of renal replacement therapy (days)(Day 0 to Day 28)
- Hospital acquired infections (incidence)(Day 0 to Day 28)
- Amount of intravenous fluid (ml)(Day 0 to Day 2)
研究者
研究点 (1)
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