Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure
NCT ID: NCT07099885
Last Updated: 2025-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-08-01
2027-01-31
Brief Summary
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A total of 90 patients will be enrolled in the study. Of these, 45 will be assigned to the algorithm-based intervention group, while the remaining 45 will serve as the control group. In the control group, all decisions regarding diuretic therapy will be made solely by the attending physician, without the use of the algorithm.
Patients will receive intravenous furosemide, with the initial dose determined by the attending physician. Two hours after administration of the diuretic, a spot urine sample will be collected to measure sodium and creatinine concentrations. Based on these values, the 6-hour urine output will be estimated using the machine learning, urine output prediction tool (http://diuresis.umw.edu.pl). This estimate will guide the diuretic therapy plan for the first 24 hours of hospitalization. On the second day, the procedure will be repeated using the same methodology.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Algorithm based decongestion
The patient will receive first dose of intravenous loop diuretic determined per the attending physician. Two hours after diuretic administration, a urine sample will be collected to measure sodium and creatinine concentrations. Using these values, the 6-hour urine output will be estimated with the aid of the machine learning, urine output prediction tool. This estimated diuresis will guide the diuretic therapy plan for the first 24 hours using the adaptative furosemide dosing.
On the second day, the procedure will be repeated.
Algorithhm-based decongestion
Patient will receive standarized furosemide dosing based on the result of the algorithm-estimated 6h urine output (profiles of diuretic response).
Standard of care
Standard of Care (SOC)
Diuretic treatment per attending physician.
Interventions
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Standard of Care (SOC)
Diuretic treatment per attending physician.
Algorithhm-based decongestion
Patient will receive standarized furosemide dosing based on the result of the algorithm-estimated 6h urine output (profiles of diuretic response).
Eligibility Criteria
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Inclusion Criteria
* Ability to enroll in the study within the first 24 hours of hospitalization
* Primary reason for hospitalization is acute heart failure with signs of congestion (at least moderate lower extremity edema)
* NT-proBNP \> 1500 pg/ml
* Anticipated need for diuretic therapy for at least 48 hours from the time of study enrollment
Exclusion Criteria
* Hemodynamic instability requiring inotropic support
* Active infection requiring intravenous antibiotic therapy
18 Years
ALL
No
Sponsors
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Wroclaw Medical University
OTHER
Responsible Party
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Jan Biegus, MD, PhD
Professor
Locations
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Wroclaw Medical University
Wroclaw, Dolnosląskie, Poland
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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226/2025
Identifier Type: -
Identifier Source: org_study_id
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