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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Poland
Wroclaw Medical University
RECRUITING
Wroclaw
Wroclaw Medical University
RECRUITING
Wroclaw
Contact Information
Primary
Jan Biegus, MD, PhD
jan.biegus@umw.edu.pl
71 736 42 05
Backup
Gracjan Iwanek, MD
gracjan.iwanek@student.umw.edu.pl
71 733 11 12
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2027-01-31
Participants
Target number of participants: 90
Treatments
Experimental: Algorithm based decongestion
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.
Active_comparator: Standard of care
Related Therapeutic Areas
Sponsors
Leads: Wroclaw Medical University

This content was sourced from clinicaltrials.gov