EUCTR2016-001940-20-GB进行中（未招募）1 期
A Pilot, Randomised, Unblinded, Feasibility, Safety, Biochemical and Physiological Efficacy Study of 20% vs 5% Human Albumin Solution for Fluid Bolus Therapy in Critically Ill Adults - Small volume resuscitation with albumin in intensive care (SWIPE)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Admitted to the intensive care unit for less than 24 hours.
- •Age 18 years or greater
- •Need for fluid bolus as determined by the treating clinician
- •Presence of one or more of the following physiological states: systolic BP <90 mmHg, or MAP <65 mmHg, or increasing need for vasopressor drug infusion or pulse pressure variation >12 % or stroke volume variation >12%, or Cardiac index <2.2 L/min/m2 or heart rate >100 or urinary output <20 ml/hr or either rising lactate levels or lactate levels >2 mmol/L or capillary refill time >3 seconds or central venous pressure <8 mmHg.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Confirmed or suspected pregnancy
- •Patients with traumatic brain injury
- •Active bleeding
- •Haemoglobin level <70 g/L
- •People who refuse blood products
- •Patients in whom death is considered imminent (within 24 hours)
研究者
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