Clinical Trial

Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure

Study acronym: SAFER-DHF
Recruiting
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Summary
The aim of this study is to evaluate the effectiveness of loop diuretic adaptative algorithm that is based on machine learning, urine output prediction tool, in decongestion of acute heart failure patients. 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-25.
Status change: Not Yet Recruiting → Recruiting 2025-08-06
Trial Details
NCT Number NCT07099885
Lead Sponsor Wroclaw Medical University
Conditions Acute Heart Failure (AHF), Congestion, Venous
Enrollment 90 participants
Start Date 2025-08-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-12