NL-OMON52060招募中4 期
Goal directed fluid removal with furosemide in intensive care patients with fluid overload - A randomised, blinded, placebo-controlled trial - GODIF
ordsjaellands Hospital, University of Copenhagen0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •All of the following criteria must be fulfilled:
- •Acute admission to the Intensive Care Unit.
- •Age >= 18 years of age.
- •Fluid overload defined as a positive cumulative fluid balance (according to
- •the daily fluid charts) corresponding >= 5 % of ideal body weight (calculated
- •as: 22 x (height in meters)^2). If possible, all fluids administered before
- •admission to the ICU are to be included in the calculation of cumulative fluid
- •Clinical stable defined as Mean Arterial Pressure > 50 mmHg and maximum
- •infusion of 0.20 microgram/kg/minute of noradrenaline and lactate < 4.0 mmol/L.
排除标准
- •Known allergy to furosemide or sulphonamides.
- •Known pre-hospitalisation advanced chronic kidney disease (eGFR < 30
- •mL/minute/1.73 m2 or chronic RRT).
- •Ongoing RRT.
- •Anuria for >= 6 hours.
- •Rhabdomyolysis with indication for forced diuresis
- •Ongoing life-threatening bleeding as these patients need specific fluid/blood
- •product strategies.
- •Acute burn injury of more than 10 % of the body surface area as these
- •patients need a specific fluid strategy.
- •Severe dysnatraemia (p-Na < 120 or > 155 mmol/l) as these patients need a
- •specific fluid strategy.
- •Severe hepatic failure as per the clinical team.
- •Patients undergoing forced treatment.
- •Fertile women (women < 50 years) with positive urine human chorionic
- •gonadotropin (hCG) or plasma-hCG.
- •Consent not obtainable as per the model approved for the specific trial site.
研究者
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