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

June 12, 2026 updated by: Jose J Zaragoza, MD MSc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mexico
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 26089
        • Recruiting
        • 76000
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Comparator: Furosemide Monotherapy
Participants receive furosemide 1 mg/kg IV as a single dose infused over 30 minutes, plus placebo (normal saline).
Drug: Furosemide (Diuretic)
Furosemide 1 mg/kg IV as a single dose, infused over 30 minutes, plus placebo (normal saline).
Experimental: Experimental: Furosemide + Albumin
Participants receive furosemide 1 mg/kg IV together with 50 g of 25% albumin, infused over 30 minutes.
Drug: Furosemide plus albumin
Furosemide 1 mg/kg IV administered together with 50 grams of 25% albumin (one vial), infused over 30 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine output (mL) at 2 hours after administration of the assigned treatment
Time Frame: 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.
2 hours after administration of the study treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in inferior vena cava (IVC) diameter and venous congestion patterns at 2 hours
Time Frame: 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.
baseline to 2 hours
Change in Serum Potassium Concentration
Time Frame: 24 hours
Change in serum potassium concentration from baseline to 24 hours after administration of the assigned treatment.
24 hours
Change in Serum Creatinine
Time Frame: Baseline to 24 hours.
Change in serum creatinine from baseline to 24 hours after administration of the assigned treatment.
Baseline to 24 hours.
Change in Serum Sodium Concentration
Time Frame: 24 hours
Change in serum sodium concentration from baseline to 24 hours after administration of the assigned treatment.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jose J Zaragoza, MD MSc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 31, 2026

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 12, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI2024a-01V2
  • FANTASTIC (Registry Identifier: FANTASTIC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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