Goal Directed Fluid Removal With Furosemide in Intensive Care Patients With Fluid Overload - A Randomised, Blinded, Placebo-controlled Trial (GODIF).
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 42
- 主要终点
- Days alive and out of hospital
研究概览
简要总结
This study evaluates the benefits and harms of goal directed fluid removal with furosemide versus placebo in critical ill adult patients with fluid overload in the intensive care unit. Half of the patients will receive furosemide and the other half placebo. The treatment will continue until the excess fluid is excreted.
详细描述
Fluid overload is a common and serious complication in patients admitted to the intensive care unit (ICU). A core element of therapy in the ICU is resuscitation with crystalloid solutions. In many cases fluid accumulate, and patients become fluid overloaded. Several observational studies indicate a detrimental effect of fluid overload in different clinical settings, including patients with acute kidney injury. It is unknown whether this association is causal or if the increased tendency to accumulate fluid is a marker of disease severity and thereby a higher risk of death. The investigators want to investigate this in critical ill patients with fluid overload of 5% or more by randomizing them to furosemide (diuretics) or placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 below must be met.
- •Acute admission to the intensive care unit.
- •Age ≥ 18 years of age
- •Fluid overload ≥ 5% of ideal body weight. If possible, all fluids administered before admission to the intensive care unit are to be included in the calculation of cumulative fluid balance.
- •Clinical stable (minimum criteria: MAP > 50 mmHg and maximum infusion of 20 microgram/kg/minute of noradrenaline and lactate < 4.0 mmol/L)
排除标准
- •Known allergy to furosemide or sulphonamides.
- •Known pre-hospitalization advanced chronic kidney disease (eGFR < 30 mL/minute/1.73 m^2 or chronic RRT).
- •Ongoing renal replacement therapy.
- •Anuria > 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 dysnatremia (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.
研究组 & 干预措施
Placebo
Isotonic saline dosed the same way and by the same algorithm as for furosemide. Start bolus of 0.5-4 ml at physicians discretion. Infusion rate: 0 - 4 ml/hour. Infusion is started at 2 ml/hour and adjusted according to effect. Target is a negative fluid balance of 1 ml/kg/hour. The fluid balance is calculated 3 times a dag at 6:00 am, 2:00 pm and 10:00 pm. Goal directed fluid removal is stopped when the fluid balance is assessed neutral.
干预措施: Isotonic saline (Drug)
Furosemide
Bolus of 5-40 mg (0.5 - 4 ml) of furosemide iv at physicians discretion followed by infusion of furosemide. Infusion rate: 0-40 mg/hour. Starting rate: 20 mg/hour. The infusion is adjusted according effect. Target is a negative fluid balance of 1 ml/kg/hour. The fluid balance is calculated 3 times a dag at 6:00 am, 2:00 pm and 10:00 pm. Goal directed fluid removal is stopped when the fluid balance is assessed neutral.
干预措施: Furosemide (Drug)
结局指标
主要结局
Days alive and out of hospital
时间窗: 90 days after randomization
Days alive and out of hospital
次要结局
- All cause mortality(90 days after randomization)
- Cognitive function(1 year after randomization)
- Serious adverse events and reactions(90 days)
- Mortality and life support(90 days after randomization)
- Mortality 1 year(one year after randomization)
- Health related quality of life(1 year after randomization)
研究者
Morten H. Bestle
Senior staff specialist and Professor
Nordsjaellands Hospital