A Single-centre, Randomized, Double-blinded, Placebo-controlled Pilot Study to Determine the Feasibility of a Full-scale Clinical Trial to Compare the Effect of Furosemide With or Without 25% Albumin in the Diuresis of Edema in Volume-overloaded ICU Patients in the Post-resuscitation Phase of Illness.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Ventilator-free Days
研究概览
简要总结
Critically ill patients usually require intravenous fluids to correct low blood pressure and improve blood flow to vital organs. However, once the patient's blood pressure has improved, these fluids can leak out into various organs, including the lung, kidneys, and skin. Excess fluid in these tissues, called edema, has been associated with longer ICU stays and higher mortality. Thus removing excess fluid is an important goal. The simplest way to treat edema is to use diuretics, such as furosemide, which increase urine output.
To further improve urine output, patients are sometimes given albumin, a protein which helps to suck fluid out from the tissues, and keep it in the blood vessel, where it can be filtered in the kidney and removed in the urine. Although albumin is often used for this purpose, there is little evidence to support it. A large randomized controlled trial is needed to determine if albumin plus furosemide is truly more effective than furosemide alone in critically ill patients with low levels of blood albumin. We will perform a pilot study to assess the feasibility of such a trial.
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
- •Hemodynamically stable for at least 24 hours (absence of persistent [>1 h] hypotension [systolic blood pressure <90 mmHg), not currently on vasopressors, less than 2 L crystalloid or colloid boluses, or 2 units red blood cells administered, maintenance fluids excluded
- •Hypoproteinemia (serum albumin <30 mg/L or total protein < 60 mg/L)
- •Clinical decision to diurese at least 3 L net fluid balance within the next 72 hours for any reason
排除标准
- •known pregnancy
- •patient or surrogate unable or unwilling to consent to blood product administration, including albumin
- •history of adverse reactions or allergy to either albumin or furosemide
- •acute kidney injury (RIFLE criteria "F" or greater) without any improvement in past 24 hours, or otherwise expected to necessitate dialysis within 48 hours in opinion of treating physician
- •chronic kidney injury requiring dialysis
- •clinically documented cirrhosis
- •clinically documented nephrotic syndrome
- •serum sodium greater than 150 milliequivalent/L or serum potassium less than 2.5 mEq/L that connote be treated prior to administration of study treatment
- •inability to measure urine output and fluid balance
- •Receipt of hyperoncotic albumin within preceding 24 hours
- •previous enrollment in this trial, or any research studies which may interfere with this study
- •estimated survival or ICU stay less than 72 hours
研究组 & 干预措施
Intravenous albumin
Administration of 25% albumin by intravenous infusion, twice daily for a total of 72 hours (6 treatments)
干预措施: Intravenous albumin (Drug)
Normal saline
Administration of 100 mL normal saline by intravenous infusion, twice daily, for 72 hours (6 treatments)
干预措施: Normal saline (Drug)
结局指标
主要结局
Ventilator-free Days
时间窗: 30 days
Ventilator-free days
次要结局
- Oxygenation(Day 1, Day 3, Day 5)
- Treatment Interruptions(Day 1, Day 2, Day 3)
- Length of ICU Stay(Study end)
- Serum Albumin and Colloid Osmotic Pressure(Day 1, Day 3, Day 5)
- Mortality(30 days)
- Duration of Mechanical Ventilation(30 days)
- Fluid Balance and Body Weight(Day 1, Day 3, Day 5)