EUCTR2019-004292-40-FI进行中（未招募）1 期
Goal directed fluid removal with furosemide in intensive care patients with fluid overload - A randomised, blinded, placebo-controlled trial (GODIF).
Department of Anesthesia and Intensive Care Medicine, Nordsjællands hospital0 个研究点目标入组 150 人开始时间: 2021年2月23日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •All of the parameters must be met:
- •Acute admission to the ICU.
- •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.
- •Clinical stable defined as MAP > 50 mmHg and maximum infusion of 20 microgram/kg/minute of noradrenaline and lactate < 4,0 mmol/L.
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 800
排除标准
- •Known allergy to furosemide or sulphonamides.
- •Known pre-hospitalization advanced chronic kidney disease (eGFR<30 mL/minute/1.73 m2 or chronic renal replacement therapy).
- •Ongoing renal replacement therapy
- •Anuria for = 6 hours
- •Rhabdomyolysis with indication for forced diuresis
- •Ongoing life-threatening bleeding.
- •Acute burn injury of more than 10 % of the body surface area.
- •Severe dysnatremia (p-Na < 120 mmol/L or >155 mmol/l).
- •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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