Urine Output DecreasedFANTASTICNCT07417969
"Effect of Albumin Combined With Furosemide in Critically Ill Patients With Fluid Overload: Impact on Urine Output and Renal Function"
A study testing Furosemide plus albumin and Furosemide (Diuretic) in people with Urine Output Decreased, run by Jose J Zaragoza, MD MSc at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Urine Output Decreased
- What is being tested?
- Furosemide plus albumin and Furosemide (Diuretic)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jun 2025to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
76000
Querétaro City, Querétaro, 26089
Alina Elizabeth Arechiga Casas, MD, +52 8781360564, alieliac26@gmail.com
About this study
Official title: "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.
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.
- Conditions
- Urine Output Decreased
- Being tested
- Furosemide plus albumin, Furosemide (Diuretic)
- Keywords
- furosemide, albumin, fluid overload, diuretics, urine output
- Medical subject headings
- Oliguria, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide plus albuminDrug
Furosemide 1 mg/kg IV administered together with 50 grams of 25% albumin (one vial), infused over 30 minutes.
Furosemide (Diuretic)Drug
Furosemide 1 mg/kg IV as a single dose, infused over 30 minutes, plus placebo (normal saline).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Furosemide plus albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours after administration of the study treatment.
Secondary outcomes (4)
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.
Measured: baseline to 2 hours
Change in Serum Potassium Concentration
Change in serum potassium concentration from baseline to 24 hours after administration of the assigned treatment.
Measured: 24 hours
Change in Serum Creatinine
Change in serum creatinine from baseline to 24 hours after administration of the assigned treatment.
Measured: Baseline to 24 hours.
Change in Serum Sodium Concentration
Change in serum sodium concentration from baseline to 24 hours after administration of the assigned treatment.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Jun 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urine Output DecreasedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jose J Zaragoza, MD MSc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417969
- Sponsor's protocol ID
- CEI2024a-01V2
- Other IDs
- FANTASTIC
- Acronym
- FANTASTIC
- Status last verified
- Jun 2026
- First submitted
- 11 Feb 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Comparison of Furosemide Versus Albumin Plus Furosemide in Increasing Urine Output in Critically Ill Patients: A Double-Blind Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT07417969
- Acronym / sponsor ID
- FANTASTIC / CEI2024a-01V2
- Conditions
- Urine Output Decreased
- Keywords
- furosemide, albumin, fluid overload, diuretics, urine output
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Jose J Zaragoza, MD MScUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Furosemide Monotherapy | Active comparator | Drug: Furosemide (Diuretic)Participants receive furosemide 1 mg/kg IV as a single dose infused over 30 minutes, plus placebo (normal saline). |
| Experimental: Furosemide + Albumin | Experimental | Drug: Furosemide plus albuminParticipants receive furosemide 1 mg/kg IV together with 50 g of 25% albumin, infused over 30 minutes. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Furosemide plus albuminFurosemide 1 mg/kg IV administered together with 50 grams of 25% albumin (one vial), infused over 30 minutes. | Drug | Experimental: Furosemide + Albumin |
| Furosemide (Diuretic)Furosemide 1 mg/kg IV as a single dose, infused over 30 minutes, plus placebo (normal saline). | Drug | Active Comparator: Furosemide Monotherapy |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Furosemide plus albumin and Furosemide (Diuretic) in people with Urine Output Decreased, run by Jose J Zaragoza, MD MSc at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alina Elizabeth Arechiga Casas, MD (+52 8781360564, alieliac26@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine output (mL) at 2 hours after administration of the assigned treatment (time frame: 2 hours after administration of the study treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.