Restrictive Fluid Administration vs. Standard of Care in Emergency Department Sepsis Patients - a Multicenter, Randomized Clinical Feasibility Trial (REFACED Sepsis)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 3
- 主要终点
- 24-hour crystalloid iv. fluids
研究概览
简要总结
This is an investigator-initiated, multicenter, randomized, parallel-group, open-labeled, feasibility trial investigating volumes of fluid within 24 hours in 124 patients with sepsis allocated to two different IV fluid regimens enrolled at three emergency departments in Central Region Denmark. The primary outcome is total intravenous, crystalloid fluid volume within 24 hours and key secondary outcomes include protocol violations, total fluids (intravenous and oral) within 24 hours, SAEs/SUSARs, and inhospital-, 30- and 90-day mortality.
详细描述
BACKGROUND:
Sepsis is common in emergency department (ED) patients. Traditionally, intravenous (IV) fluids are used to optimise the circulation, and the use of higher volumes is recommended by international guidelines, but there are no recommendations for sepsis without hypotension or shock. Studies in septic shock seem to favour fluid restriction. Whether this is true in sepsis without hypotension/shock is unknown.
OBJECTIVES:
The aim of the REFACED Sepsis trial is to test if an IV fluid restrictive protocol in ED patients with sepsis is feasible, i.e., if the protocol decreases the IV fluid volumes administered.
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
- 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
- •All of the below must be fulfilled:
- •Unplanned emergency department admission
- •Age ≥ 18 years
- •Sepsis defined as
- •suspected infection by the treating clinician AND
- •blood cultures drawn AND
- •IV antibiotics administered or planned AND
- •An infection related increase of SOFA*-score ≥ 2 from baseline
- •Expected hospital stay > 24 hours as deemed by treating clinician
- •Sequential Organ Failure Assessment (SOFA) Score
- •Further more the patient must fulfill criteria for enrollment in an acute study according to Danish law
排除标准
- •We will exclude patients fulfilling any of following exclusion criteria:
- •≥ 500 ml of fluids given prior to randomization
- •Invasively ventilated or vasopressors initiated at the time of screening
- •Known or suspected severe bleeding judged by the treating clinician
- •Known or suspected pregnancy (women aged <45 years will have a pregnancy test performed before enrollment)
- •Prior enrollment in the trial
- •Patients, who the clinician expect not to survive the next 24-hours
研究组 & 干预措施
Restrictive fluid administration
No IV fluids unless one of the extenuating circumstances occur;
- In case of severe hypoperfusion or severe circulatory impairment defined by either: 1) Lactate≥4 mmol/L, 2) Hypotension (systolic BP < 90 mmHg), 3) Mottling beyond the kneecap (mottling score >2) OR 4) Urinary output<0.1 mL/kg bodyweight/h (only in the first 4hrs after randomization) then a bolus of 250 ml of IV crystalloid solution may be given followed by re-evaluation
- 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.
- 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 1 L in 24hrs 4. IV fluids may be given as carrier for medication, but with lowest possible volume
干预措施: Isotonic crystalloids (Drug)
Usual care (standard care)
There will be no upper limit for the use of either IV or oral/enteral fluids
- 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
24-hour crystalloid iv. fluids
时间窗: 24 hours from randomization
total amount of all administered intravenous, crystalloid fluids within 24 hours of randomization
次要结局
- Time to inclusion(Through study completion, an average of 1 year)
- Lost-to-follow-up-rate(24 hours from randomization)
- Protocol violations(24 hours from randomization)
- Screened-vs.-randomized-ratio(Through study completion, an average of 1 year)
- Accumulated serious adverse reactions (SARs + SUSARs)(7 days from randomization)
- Total 24-hour fluids(24 hours from randomization)
- Mortality(Total of 90-days)
研究者
Marie Kristine Jessen, MD
Principal Investigator
University of Aarhus