EUCTR2021-000224-35-DK进行中（未招募）1 期
Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients - a Multicenter, Randomized Clinical Feasibility Trial - REFACED Sepsis
Marie Kristine Jessen0 个研究点目标入组 124 人开始时间: 2021年5月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 124
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
- 性别
- All
入选标准
- •We will include patients fulfilling the following:
- •1)Unplanned emergency department admission
- •2)Age = 18 years
- •3)Sepsis defined as
- •a) suspected infection by the treating clinician AND
- •b) blood cultures drawn AND
- •c) IV antibiotics administered or planned AND
- •d) An infection related increase of SOFA-score = 2 from baseline
- •4)Expected hospital stay > 24 hours as deemed by treating clinician
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 74
排除标准
- •We will exclude patients fulfilling any of following exclusion criteria:
- •1) = 500 ml of fluids given prior to randomization
- •2) Invasively ventilated or vasopressors initiated at the time of screening
- •3) Known or suspected severe bleeding judged by the treating clinician
- •4) Known or suspected pregnancy (women aged <45 years will have a pregnancy test performed before enrollment)
- •5) Prior enrollment in the trial
- •6) Patients, who the clinician expect not to survive the next 24-hours
研究者
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