NCT03528213已完成2 期
Utility of Sodium Lactate Infusion During Septic Shock: Pilot Study
University Hospital, Lille7 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2019年10月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 7
- 主要终点
- fluid balance
研究概览
简要总结
ULIS-1 is an open-label pilot study concerning utility of molar sodium lactate in fluid balance in septic shock patients
详细描述
ULIS-1 consists in three arms of treatment during the first 24hrs of septic shock treatment.
- normal saline
- sodium lactate 2.5ml/kg in 60min then
- either 0.25 or 0.5ml/kg/h during 24hrs Main criteria is fluid balance at 48hrs
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
- •Presence of septic shock
- •requiring vascular filling within 12 hours after introduction of Noradrenaline. Septic shock is defined as sepsis with persistent hypotension requiring the administration of vasopressors to maintain RTE > 65mmHg.
- •social insurance
排除标准
- •pregnancy
- •cardiac arrest
- •more than 50ml/kg of fluid loading
- •chronic renal failure with chronic hemodialysis or the investigators estimate a need for renal replacement therapy in the following 24hrs
- •child C or acute liver failure with PT<40% (unless AVK)
- •plasmatic sodium <120 or >145mmol/l
- •metabolic alkalosis with pH>7.45
研究组 & 干预措施
Normal saline
Sham Comparator
at physician discretion
干预措施: Normal saline (Drug)
Sodium lactate light dose
Experimental
bolus 2.5ml/kg lactate 60min then 0.25ml/kg/h during 24hrs
干预措施: Sodium Lactate light dose (Drug)
Sodium lactate high dose
Experimental
bolus 2.5ml/kg lactate 60min then 0.50ml/kg/h during 24hrs
干预措施: Sodium Lactate high dose (Drug)
结局指标
主要结局
fluid balance
时间窗: at 48 hours
fluid balance
次要结局
- fluid balance at day 7(Day 7)
- number of patients dead(Day 28)
- hypokaliemia(Day 2)
- metabolic alkalosis(day 2)
- SOFA (Sequential Organ Failure Assessment)(Day 1, Day 2, Day 3, Day 7)
- death in hospital(Day 90)
- catecholamines free days(Day 28)
- death in Intensive Care Unit (ICU)(Day 90)
- new kidney failure(Day 28)
- nosocomial infections(day 90)
- hypernatremia(Day 2)
- ventilator free days(Day 28)
- renal replacement therapy free days(Day 28)
- hemodynamic effects assessed by the PICCO® monitoring system(at 48 hours)
研究者
研究点 (7)
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