Urine Output Decreased
Conditions
Keywords
furosemide, albumin, fluid overload, diuretics, urine output
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.
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
DRUGFurosemide plus albumin
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).
Sponsors
Jose J Zaragoza, MD MSc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Mexico
Contacts
CONTACTAlina Elizabeth Arechiga Casas, MD
Outcome results
None listed