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

NCT07417969 | Recruiting

• 2 other identifiers: CEI2024a-01V2FANTASTIC
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Urine Output Decreased

Keywords

furosemide; albumin; fluid overload; diuretics; urine output

Outcome Measures

Primary Outcomes (1)

• Urine output at 2 hours

  Urine output measured in milliliters at 2 hours after administration of the assigned treatment (furosemide alone or furosemide plus albumin). Measurement performed with standard urine collection devices by blinded staff.

  2 hours after administration of the study treatment.

Secondary Outcomes (3)

• Ultrasound assessment of fluid overload

  baseline to 2 hours

• Electrolyte changes (Na, K, Cl)

  Baseline to 24 hours.

• Change in serum creatinine

  Baseline to 24 hours.

Study Arms (2)

Active Comparator: Furosemide Monotherapy

ACTIVE COMPARATOR

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

Drug: Furosemide (Diuretic)

Experimental: Furosemide + Albumin

EXPERIMENTAL

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

Drug: Furosemide plus albumin

Interventions

Furosemide plus albumin DRUG

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

Experimental: Furosemide + Albumin

Furosemide (Diuretic) DRUG

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

Active Comparator: Furosemide Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jose J Zaragoza, MD MSc: lead

Study Sites (1)

76000

Querétaro City, Querétaro, 26089, Mexico

RECRUITING

MeSH Terms

Conditions

Oliguria; Edema

Interventions

Furosemide; Albumins; Diuretics

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Proteins; Amino Acids, Peptides, and Proteins; Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Alina Elizabeth Arechiga Casas, MD

CONTACT

+52 8781360564; alieliac26@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study uses a double-blind design. Both participants and care providers are masked to treatment allocation. Patients are randomized in a 1:1 ratio to receive either furosemide 1 mg/kg plus placebo or furosemide 1 mg/kg plus 50 g of intravenous albumin. An independent staff member prepares the study solutions in identical opaque containers with equal volumes to preserve blinding. Clinical evaluations, including urine output measurement at 2 hours and bedside ultrasound assessment of fluid overload, are performed without revealing the assigned group. Blinding is maintained throughout the study until data collection is complete and the database is locked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator / Principal Investigator

Model Details: This study uses a randomized, parallel-group design in which participants are assigned to one of two treatment arms: furosemide monotherapy or the combination of furosemide plus albumin. Each participant receives only one intervention throughout the study. Urine output is measured at 2 hours after administration, along with serum and urine biochemical markers, hemodynamic variables, and bedside ultrasound indicators of fluid overload. These outcomes are compared between groups to evaluate differences in diuretic response and renal function.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

ME (1)