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RecruitingNCT07417969FANTASTICUpdated Jun 16, 2026

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

An interventional study of Furosemide plus albumin and Furosemide (Diuretic) in Urine Output Decreased, sponsored by Jose J Zaragoza, MD MSc. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by Jose J Zaragoza, MD MSc · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jun 2025, registered Feb 2026).
  • Started Jun 2025; still recruiting 1 year 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Urine Output Decreased

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Keywords

  • furosemide
  • albumin
  • fluid overload
  • diuretics
  • urine output
03

In context

Edema

566 studies on the registry are indexed under Edema; 95 are open to participants now.

This study's planned enrollment of 56 is close to the median of 52 across 401 interventional studies indexed under Edema.

Browse Edema studies →

Lead sponsor

This is the only study on the registry with Jose J Zaragoza, MD MSc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
56 participants (estimated)

Study arms

  • 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)

  • 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

Interventions

  • DrugFurosemide plus albumin

    Drug pages: Furosemide · Albumins

    Furosemide 1 mg/kg IV administered together with 50 grams of 25% albumin (one vial), infused over 30 minutes.

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

06

What researchers measure

Primary outcomes

  1. Urine output (mL) at 2 hours after administration of the assigned 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.

    Time frame: 2 hours after administration of the study treatment.

Secondary outcomes

  1. Change in inferior vena cava (IVC) diameter and venous congestion patterns at 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.

    Time frame: baseline to 2 hours

  2. Change in Serum Potassium Concentration

    Change in serum potassium concentration from baseline to 24 hours after administration of the assigned treatment.

    Time frame: 24 hours

  3. Change in Serum Creatinine

    Change in serum creatinine from baseline to 24 hours after administration of the assigned treatment.

    Time frame: Baseline to 24 hours.

  4. Change in Serum Sodium Concentration

    Change in serum sodium concentration from baseline to 24 hours after administration of the assigned treatment.

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
  • 76000
    Querétaro City, Querétaro 26089, Mexico
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07417969
Lead sponsor
Jose J Zaragoza, MD MSc
Responsible party
Jose J Zaragoza, MD MSc (Sponsor-Investigator / Principal Investigator, Hospital H+ Queretaro) — Sponsor-investigator
First posted
Feb 18, 2026
Start date
Jun 1, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Jun 16, 2026

Study contacts

Alina Elizabeth Arechiga Casas, MD
Contact
alieliac26@gmail.com
+52 8781360564

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Furosemide · Albumins

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