Health TrialsbyHealthPanel

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

ConditionsAcute Heart Failure (AHF)Congestion, Venous
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWroclaw Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

End-stage kidney disease requiring renal replacement therapy

Hemodynamic instability requiring inotropic support

Active infection requiring intravenous antibiotic therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care (SOC)

    Diagnostic test

    Diuretic treatment per attending physician.

  • 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).

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Algorithm based decongestionExperimental treatment 1 intervention
Group B: Standard of careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Cumulative diuresis over 48 hours.

Total urine output during the 48-hour duration of the study.

Time frame
48 hours

Secondary outcomes

1

Cumulative diuresis during first 24h of the study.

The total urine output during the first 24 hours of the study.

Time frame
24 hours
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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Wroclaw Medical University

Lead sponsor

Source ClinicalTrials.gov
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