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

Jose J Zaragoza, MD MSc

Status: Enrolling

Conditions: Urine Output Decreased

Treatments: Drug: Furosemide (Diuretic); Drug: Furosemide plus albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT07417969

FANTASTIC (Registry Identifier)

CEI2024a-01V2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Adults ≥ 18 years of age admitted to the intensive care unit (ICU) without mechanical ventilation.

Patients for whom diuretic therapy will be initiated for the first time during the ICU stay due to clinical signs of fluid overload, as determined by the treating physician.

Exclusion criteria

Patients or family members who refuse participation in the study.

Patients receiving palliative care.

Patients with kidney failure requiring renal replacement therapy.

Patients currently participating in another clinical research protocol.

Patients with clinical evidence of hypovolemia or dehydration.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups

Active Comparator: Furosemide Monotherapy

Active Comparator group

Description:

Participants receive furosemide 1 mg/kg IV as a single dose infused over 30 minutes, plus placebo (normal saline).

Treatment:

Drug: Furosemide (Diuretic)

Experimental: Furosemide + Albumin

Experimental group

Description:

Participants receive furosemide 1 mg/kg IV together with 50 g of 25% albumin, infused over 30 minutes.

Treatment:

Drug: Furosemide plus albumin