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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Algorithm based decongestion | Experimental | 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. |
|
| Standard of care | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care (SOC) | Diagnostic Test | Diuretic treatment per attending physician. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative diuresis over 48 hours. | Total urine output during the 48-hour duration of the study. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative diuresis during first 24h of the study. | The total urine output during the first 24 hours of the study. | 24 hours |
| Cumulative diuresis on the second 24h of the study. | The total urine output during the second 24 hours of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Biegus, MD, PhD | Contact | 71 736 42 05 | 0048 | jan.biegus@umw.edu.pl |
| Gracjan Iwanek, MD | Contact | 71 733 11 12 | 0048 | gracjan.iwanek@student.umw.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wroclaw Medical University | Recruiting | Wroclaw | DolnoslÄ…skie | 50-556 | Poland |
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| Algorithhm-based decongestion |
| Diagnostic Test |
Patient will receive standarized furosemide dosing based on the result of the algorithm-estimated 6h urine output (profiles of diuretic response). |
|
| 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. | 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. | 48 hours |
| Weight change at 24 hours. | The difference in body weight measured at 24 hours compared to baseline. | 24 hours |
| Weight change at 48 hours. | The difference in body weight measured at 48 hours compared to baseline. | 48 hours |
| Total length of hospitalization. | This refers to the total length of the hospital stay, measured in days, from admission to discharge. | 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. | 48 hours |
| Wroclaw Medical University | Recruiting | Wroclaw | Lower Silesian Voivodeship | 50-556 | Poland |
| ID | Term |
|---|---|
| D006940 | Hyperemia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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