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| ID | Type | Description | Link |
|---|---|---|---|
| FANTASTIC | Registry Identifier | FANTASTIC |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Experimental: Furosemide + Albumin | Experimental | Participants receive furosemide 1 mg/kg IV together with 50 g of 25% albumin, infused over 30 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Furosemide plus albumin | Drug | Furosemide 1 mg/kg IV administered together with 50 grams of 25% albumin (one vial), infused over 30 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 hours after administration of the study treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline to 2 hours |
| Change in Serum Potassium Concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alina Elizabeth Arechiga Casas, MD | Contact | +52 8781360564 | alieliac26@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 76000 | Recruiting | Querétaro City | Querétaro | 26089 | Mexico |
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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.
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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.
| Furosemide (Diuretic) | Drug | Furosemide 1 mg/kg IV as a single dose, infused over 30 minutes, plus placebo (normal saline). |
|
Change in serum potassium concentration from baseline to 24 hours after administration of the assigned treatment. |
| 24 hours |
| Change in Serum Creatinine | Change in serum creatinine from baseline to 24 hours after administration of the assigned treatment. | 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. | 24 hours |
| ID | Term |
|---|---|
| D009846 | Oliguria |
| D004487 | Edema |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005665 | Furosemide |
| D000418 | Albumins |
| D004232 | Diuretics |
| ID | Term |
|---|---|
| D013424 | Sulfanilamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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