"Comparison of Furosemide Versus Albumin Plus Furosemide in Increasing Urine Output in Critically Ill Patients: A Double-Blind Randomized Clinical Trial"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Urine output (mL) at 2 hours after administration of the assigned treatment
研究概览
简要总结
This study aims to compare the effectiveness of furosemide alone versus the combination of furosemide plus albumin in critically ill adult patients with fluid overload. The trial evaluates whether co-administration of albumin enhances diuretic response compared with standard furosemide therapy. The primary outcomes include urine output at 2 hours, changes in renal perfusion markers, and biochemical parameters. Secondary outcomes include changes in mean arterial pressure, electrolyte balance, and renal resistance index. The study seeks to determine whether adding albumin provides a clinically meaningful improvement in diuresis and renal function compared with furosemide monotherapy.
详细描述
This randomized clinical study evaluates two diuretic strategies for fluid overload in adult critically ill patients: furosemide monotherapy versus combined therapy with furosemide plus albumin. Albumin may enhance diuretic effectiveness by increasing intravascular oncotic pressure, improving renal perfusion, and facilitating drug delivery to the nephron.
The protocol includes standardized dosing, measurement of urine output at 2 hours, and analysis of serum and urine biochemical parameters. Bedside ultrasound will be used to assess markers of fluid overload, including evaluation of the inferior vena cava and venous congestion patterns. Hemodynamic variables, electrolyte changes, and estimated glomerular filtration rate will also be monitored.
The study aims to determine whether the co-administration of albumin provides a clinically meaningful improvement in diuretic response and renal function compared with furosemide monotherapy in critically ill patients with fluid overload.
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)
盲法说明
This study uses a double-blind design. Both participants and care providers are masked to treatment allocation. Patients are randomized in a 1:1 ratio to receive either furosemide 1 mg/kg plus placebo or furosemide 1 mg/kg plus 50 g of intravenous albumin. An independent staff member prepares the study solutions in identical opaque containers with equal volumes to preserve blinding.
Clinical evaluations, including urine output measurement at 2 hours and bedside ultrasound assessment of fluid overload, are performed without revealing the assigned group. Blinding is maintained throughout the study until data collection is complete and the database is locked.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years
- •Critically ill patients admitted to the intensive care unit (ICU)
- •Presence of oliguria defined as urine output <0.5 mL/kg/hour for at least 6 hours
排除标准
- •Refusal to participate by the patient or legal representative
- •Patients receiving palliative or end-of-life care
- •Acute or chronic kidney failure requiring ongoing renal replacement therapy at enrollment
- •Chronic dialysis dependency
- •Participation in another interventional clinical trial
- •Pregnant or lactating women
研究组 & 干预措施
Experimental: Furosemide + Albumin
Participants receive furosemide 1 mg/kg IV together with 50 g of 25% albumin, infused over 30 minutes.
干预措施: Furosemide plus albumin (Drug)
Active Comparator: Furosemide Monotherapy
Participants receive furosemide 1 mg/kg IV as a single dose infused over 30 minutes, plus placebo (normal saline).
干预措施: Furosemide (Diuretic) (Drug)
结局指标
主要结局
Urine output (mL) at 2 hours after administration of the assigned treatment
时间窗: 2 hours after administration of the study treatment.
Total urine output measured in milliliters within the first 2 hours after administration of the assigned treatment (furosemide alone or furosemide plus albumin), using a urinary catheter and standard collection methods.
Urine output at 2 hours
时间窗: 2 hours after administration of the study treatment.
Urine output measured in milliliters at 2 hours after administration of the assigned treatment (furosemide alone or furosemide plus albumin). Measurement performed with standard urine collection devices by blinded staff.
次要结局
- Change in inferior vena cava (IVC) diameter and venous congestion patterns at 2 hours(baseline to 2 hours)
- Change in Serum Potassium Concentration(24 hours)
- Change in Serum Creatinine(Baseline to 24 hours.)
- Change in Serum Sodium Concentration(24 hours)
- Ultrasound assessment of fluid overload(baseline to 2 hours)
- Electrolyte changes (Na, K, Cl)(Baseline to 24 hours.)
- Change in serum creatinine(Baseline to 24 hours.)
研究者
Jose J Zaragoza, MD MSc
Sponsor-Investigator / Principal Investigator
Hospital H+ Queretaro