Actively Recruiting
Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure
Led by Wroclaw Medical University · Updated on 2025-08-12
90
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a machine learning-based loop diuretic adaptive algorithm to improve decongestion in patients hospitalized with acute heart failure showing signs of congestion. This trial aims to compare this algorithm-guided diuretic therapy with standard care managed solely by attending physicians. The study will enroll 90 adult patients who require intravenous diuretic treatment and have significant congestion symptoms. Participants will be randomly assigned to either the algorithm-based intervention group or the control group receiving standard care. All patients receive an initial dose of intravenous furosemide determined by their physician. Two hours after dosing, a urine sample is collected to measure sodium and creatinine levels. These values are used by the algorithm to estimate the six-hour urine output, which then guides diuretic dosing for the first 24 hours. This procedure repeats on the second day to adjust treatment plans. During the trial, researchers will monitor urine output cumulatively over 48 hours as the primary outcome. Secondary measures include urine output and sodium excretion over 24 and 48 hours, weight changes, length of hospital stay, and accuracy of patient response prediction. Participants will undergo urine sampling, diuretic dosing adjustments, and clinical evaluations throughout their hospitalization, which may last up to 60 days. The study assesses the effectiveness and safety of algorithm-guided diuretic therapy in managing acute heart failure congestion.
CONDITIONS
Brief Title
Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- End-stage kidney disease requiring renal replacement therapy
- Hemodynamic instability requiring inotropic support
- Active infection requiring intravenous antibiotic therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 24 hours from hospitalization
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 48 hours
Participants receive diuretic therapy guided by an algorithm estimating 6-hour urine output or standard care based on attending physician decisions. Urine samples are collected after diuretic administration to adjust treatment during the first 48 hours.
2 in-person visits over 2 days for urine sample collection and treatment adjustment
Duration - Up to 60 days
Participants are monitored for clinical outcomes including weight change and length of hospitalization following treatment.
Visits as needed during hospitalization up to 60 days
Trial Site Locations
Total: 2 locations
1
Wroclaw Medical University
Wroclaw, Dolnosląskie, Poland, 50-556
Actively Recruiting
2
Wroclaw Medical University
Wroclaw, Lower Silesian Voivodeship, Poland, 50-556
Actively Recruiting
Research Team
J
Jan Biegus, MD, PhD
G
Gracjan Iwanek, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here