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

NCT07417969 — Not applicable, Recruiting, 56 participants, Jose J Zaragoza, MD MSc

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

RegistryNCT07417969, acronym FANTASTIC
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment56 (Estimated)
SponsorJose J Zaragoza, MD MSc (Other)
ConditionsUrine Output Decreased
InterventionsFurosemide plus albumin, Furosemide (Diuretic) (Drug)
Datesstart 2025-06-01, primary completion 2026-09-30 (estimated), completion 2026-10-31 (estimated), first posted 2026-02-18, last updated 2026-06-16
Locations1 site in Mexico

Related Papers Related Patents Related Grants Related Experts
All trials for Urine Output Decreased All trials of Furosemide plus albumin All trials of Furosemide (Diuretic)

-Summary

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.

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+Detailed 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.

+Arms and interventions

ArmTypeInterventionsDescription
Active Comparator: Furosemide MonotherapyActive comparatorDrug: Furosemide (Diuretic)Participants receive furosemide 1 mg/kg IV as a single dose infused over 30 minutes, plus placebo (normal saline).
Experimental: Furosemide + AlbuminExperimentalDrug: Furosemide plus albuminParticipants receive furosemide 1 mg/kg IV together with 50 g of 25% albumin, infused over 30 minutes.
  • Furosemide plus albumin (Drug): Furosemide 1 mg/kg IV administered together with 50 grams of 25% albumin (one vial), infused over 30 minutes.
  • Furosemide (Diuretic) (Drug): Furosemide 1 mg/kg IV as a single dose, infused over 30 minutes, plus placebo (normal saline).

+Outcome measures

Primary outcomes

  • Urine output (mL) at 2 hours after administration of the assigned treatment [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.

Secondary outcomes

  • Change in inferior vena cava (IVC) diameter and venous congestion patterns at 2 hours [baseline to 2 hours]: Change in inferior vena cava (IVC) diameter (mm) and venous congestion patterns assessed by bedside ultrasound from baseline to 2 hours after treatment administration.
  • Change in Serum Potassium Concentration [24 hours]: Change in serum potassium concentration from baseline to 24 hours after administration of the assigned treatment.
  • Change in Serum Creatinine [Baseline to 24 hours.]: Change in serum creatinine from baseline to 24 hours after administration of the assigned treatment.
  • Change in Serum Sodium Concentration [24 hours]: Change in serum sodium concentration from baseline to 24 hours after administration of the assigned treatment.

+Eligibility

Sex: All, ages: 18 Years to 100 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (1)

FacilityCityCountryStatus
76000Querétaro City, QuerétaroMexicoRecruiting