An interventional study of Standard of Care (SOC) and Algorithhm-based decongestion in Acute Heart Failure (AHF) and Congestion, Venous, sponsored by Wroclaw Medical University. Recruiting at 2 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by Wroclaw Medical University · Not applicable, Interventional, and Treatment
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.
98 studies on the registry are indexed under Hyperemia; 44 are open to participants now.
This study's planned enrollment of 90 is above the median of 68 across 51 interventional studies indexed under Hyperemia.
Browse Hyperemia studies →Wroclaw Medical University is the lead sponsor of 99 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: Algorithhm-based decongestion
Diagnostic Test: Standard of Care (SOC)
Diuretic treatment per attending physician.
Patient will receive standarized furosemide dosing based on the result of the algorithm-estimated 6h urine output (profiles of diuretic response).
Cumulative diuresis over 48 hours.
Total urine output during the 48-hour duration of the study.
Time frame: 48 hours
Cumulative diuresis during first 24h of the study.
The total urine output during the first 24 hours of the study.
Time frame: 24 hours
Cumulative diuresis on the second 24h of the study.
The total urine output during the second 24 hours of the study.
Time frame: 48 hours
Cummulative natriuresis over 48 hours of the study.
The total amount of sodium excreted in the urine during the 48-hour duration of the study.
Time frame: 48 hours
Diuresis calculated per dose of loop diuretic over 48 hours of the study.
The volume of urine output relative to the total dose of loop diuretic administered during the study period.
Time frame: 48 hours
Weight change at 24 hours.
The difference in body weight measured at 24 hours compared to baseline.
Time frame: 24 hours
Weight change at 48 hours.
The difference in body weight measured at 48 hours compared to baseline.
Time frame: 48 hours
Total length of hospitalization.
This refers to the total length of the hospital stay, measured in days, from admission to discharge.
Time frame: Up to 60 days
Percentage of patients accurately red-flagged.
Patients with an estimated 6-hour urine output of less than 900 ml will be red-flagged. This outcome indicates the proportion of patients who were correctly identified (red-flagged) as poor diuretic responders.
Time frame: 48 hours
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Dec 2026, 16 months after the start.
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Wroclaw Medical University