"Effect of Albumin Combined With Furosemide in Critically Ill Patients With Fluid Overload: Impact on Urine Output and Renal Function"
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Furosemide plus albumin, Furosemide (Diuretic).
- Who it may be relevant to
- Registry conditions: Urine Output Decreased. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
"Comparison of Furosemide Versus Albumin Plus Furosemide in Increasing Urine Output in Critically Ill Patients: A Double-Blind Randomized Clinical Trial"
Overview
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.
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.
Interventions
- Drug Furosemide plus albumin
Furosemide 1 mg/kg IV administered together with 50 grams of 25% albumin (one vial), infused over 30 minutes. - Drug Furosemide (Diuretic)
Furosemide 1 mg/kg IV as a single dose, infused over 30 minutes, plus placebo (normal saline).
Primary outcome measures
- Urine output (mL) at 2 hours after administration of the assigned treatment [Time frame: 2 hours after administration of the study treatment.]
Secondary outcome measures (4)
- Change in inferior vena cava (IVC) diameter and venous congestion patterns at 2 hours [Time frame: baseline to 2 hours]
- Change in Serum Potassium Concentration [Time frame: 24 hours]
- Change in Serum Creatinine [Time frame: Baseline to 24 hours.]
- Change in Serum Sodium Concentration [Time frame: 24 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- 76000 — Querétaro City
Identifiers
NCT: NCT07417969 · CEI2024a-01V2 · FANTASTIC