"Effect of Albumin Combined With Furosemide in Critically Ill Patients With Fluid Overload: Impact on Urine Output and Renal Function"

Официальное название

"Comparison of Furosemide Versus Albumin Plus Furosemide in Increasing Urine Output in Critically Ill Patients: A Double-Blind Randomized Clinical Trial"

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Furosemide plus albumin
  Furosemide 1 mg/kg IV administered together with 50 grams of 25% albumin (one vial), infused over 30 minutes.
• Препарат Furosemide (Diuretic)
  Furosemide 1 mg/kg IV as a single dose, infused over 30 minutes, plus placebo (normal saline).

Первичные конечные точки

• Urine output (mL) at 2 hours after administration of the assigned treatment [Срок оценки: 2 hours after administration of the study treatment.]

Вторичные конечные точки (4)

• Change in inferior vena cava (IVC) diameter and venous congestion patterns at 2 hours [Срок оценки: baseline to 2 hours]
• Change in Serum Potassium Concentration [Срок оценки: 24 hours]
• Change in Serum Creatinine [Срок оценки: Baseline to 24 hours.]
• Change in Serum Sodium Concentration [Срок оценки: 24 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• 76000 — Querétaro City

Идентификаторы

NCT: NCT07417969 · CEI2024a-01V2 · FANTASTIC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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