Actively Recruiting

Phase 4
Age: 18Years +
All Genders
ID07263035

Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure

Led by Lakeland Regional Health Systems, Inc. · Updated on 2026-04-09

600

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether increasing the dose of diuretics to reach a higher urine sodium target improves treatment outcomes in adults hospitalized with acute decompensated heart failure compared to standard care. The study aims to find out if targeting higher urine sodium levels leads to better natriuresis and diuresis, reduces hospital readmissions, and shortens hospital stays. Participants will be randomly assigned to one of three groups: standard care, diuretics adjusted to achieve a urine sodium concentration of 50 mmol/L, or diuretics adjusted to reach 85 mmol/L. Urine sodium levels will be checked two to four hours after intravenous diuretic administration, and if levels are low, the diuretic dose will be increased. This adjustment process will continue during the first 72 hours of hospital admission. During the trial, participants will provide urine samples at routine intervals to monitor sodium levels and treatment response. Researchers will assess natriuresis and diuresis at 24 and 48 hours, length of hospital stay, readmission rates at 30 and 90 days, weight changes, and net fluid balance. The study will last through hospitalization and follow participants up to 90 days post-discharge to evaluate clinical outcomes and safety.

CONDITIONS

Brief Title

Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years of age or older admitted with a primary diagnosis of acute decompensated heart failure
  • Presence of at least one sign of fluid overload such as bilateral lower extremity pitting edema, jugular venous distension, hepatojugular reflex, crackles on lung exam, or chest x-ray showing pulmonary edema or pleural effusions
Not Eligible

You will not qualify if you...

  • Admission to the intensive care unit
  • Presence of ST-elevated myocardial infarction
  • Presence of type 1 non-ST elevated myocardial infarction
  • Dyspnea primarily due to a non-cardiac cause
  • Use of supplemental oxygen at 3 liters per minute or greater at baseline
  • Anuria
  • End-stage renal disease as defined by KDIGO criteria
  • Current use of dialysis

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 72 hours during hospital admission

Participants receive intravenous diuretics with doses adjusted to achieve specific urine sodium concentration targets or standard care during hospitalization for acute decompensated heart failure.

Continuous monitoring during hospital stay

Follow-up

Duration - Up to 90 days after discharge

Participants are monitored for clinical outcomes including readmission rates and weight changes after hospital discharge.

Visits or contacts at 30 and 90 days post-discharge

Trial Site Locations

Total: 1 location

1

Lakeland Regional Hospital

Lakeland, Florida, United States, 33805

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Research Team

A

Andrew Lurie, DO

A

Anas Bizanti, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Frequently Asked Questions

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