Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 3:14 AM
Study NCT ID:
NCT07417969
Status:
RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Effect of Albumin Combined With Furosemide in Critically Ill Patients With Fluid Overload: Impact on Urine Output and Renal Function"
Sponsor:
Jose J Zaragoza, MD MSc
Organization:
Study Overview
Official Title:
"Comparison of Furosemide Versus Albumin Plus Furosemide in Increasing Urine Output in Critically Ill Patients: A Double-Blind Randomized Clinical Trial"
Status:
RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FANTASTIC
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| FANTASTIC | REGISTRY | FANTASTIC | View |