Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care (SOC), Algorithhm-based decongestion.
- Who it may be relevant to
- Registry conditions: Acute Heart Failure (AHF), Congestion, Venous. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test Standard of Care (SOC)
Diuretic treatment per attending physician. - Diagnostic test Algorithhm-based decongestion
Patient will receive standarized furosemide dosing based on the result of the algorithm-estimated 6h urine output (profiles of diuretic response).
Primary outcome measures
- Cumulative diuresis over 48 hours. [Time frame: 48 hours]
Secondary outcome measures (8)
- Cumulative diuresis during first 24h of the study. [Time frame: 24 hours]
- Cumulative diuresis on the second 24h of the study. [Time frame: 48 hours]
- Cummulative natriuresis over 48 hours of the study. [Time frame: 48 hours]
- Diuresis calculated per dose of loop diuretic over 48 hours of the study. [Time frame: 48 hours]
- Weight change at 24 hours. [Time frame: 24 hours]
- Weight change at 48 hours. [Time frame: 48 hours]
- Total length of hospitalization. [Time frame: Up to 60 days]
- Percentage of patients accurately red-flagged. [Time frame: 48 hours]
Eligibility criteria
Inclusion criteria
- Adult patients over 18 years of age who provide informed consent
- 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
- End-stage kidney disease requiring renal replacement therapy
- Hemodynamic instability requiring inotropic support
- Active infection requiring intravenous antibiotic therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Poland · 2 centers
- Wroclaw Medical University — Wroclaw
- Wroclaw Medical University — Wroclaw
Identifiers
NCT: NCT07099885 · 226/2025