Using urine sodium to guide IV diuretic dosing for hospitalized acute heart failure
Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure
This trial will test whether increasing IV diuretic doses to reach higher urine sodium levels helps hospitalized adults with acute decompensated heart failure remove more salt and fluid and have fewer readmissions.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Lakeland Regional Health Systems, Inc. Academic / other |
| Locations | 1 site (Lakeland, Florida) |
| Trial ID | NCT07263035 on ClinicalTrials.gov |
What this trial studies
Adults admitted with acute decompensated heart failure are randomized to one of three arms: a low urine sodium target (50 µmol), a higher urine sodium target (85 µmol), or standard of care. Urine sodium is measured 2–4 hours after intravenous furosemide and, if the natriuretic response is inadequate, the diuretic dose is increased; this approach is repeated during the first 72 hours of admission. Primary comparisons focus on natriuresis and diuresis, with secondary outcomes including hospital length of stay and readmission frequency. The trial is single-center and interventional, using a protocolized urine-sodium-guided escalation of loop diuretics versus usual care.
Who should consider this trial
Good fit: Ideal participants are adults (≥18) hospitalized at Lakeland Regional Hospital with acute decompensated heart failure and clinical signs of volume overload who are not critically ill and not on dialysis.
Not a fit: Patients admitted to intensive care, with ST-elevation MI, type 1 NSTEMI, primary non-cardiac dyspnea, anuria, end-stage renal disease, or on dialysis are unlikely to qualify or benefit from this strategy.
Why it matters
Potential benefit: If successful, this approach could speed and increase fluid removal in hospitalized patients and reduce length of stay and readmissions.
How similar studies have performed: Smaller observational and physiologic studies have shown urine sodium can predict diuretic response, but randomized outcome data using urine-sodium-guided dosing are limited, making this a relatively novel outcome-focused approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* The study will target adults 18 years of age or older admitted to Lakeland Regional Medical Center who:
* Have a primary diagnosis of acute decompensated heart failure, and
* Have at least one of the following signs of hypervolemia:
* Bilateral lower extremity pitting edema
* Jugular venous distension
* Hepatojugular reflex
* Crackles on pulmonary exam, or
* Chest x-ray demonstrating pulmonary edema or pleural effusions
Exclusion Criteria:
* Exclusion criteria include:
* 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 non-cardiac cause as judged by the emergency medicine physician or admitting physician
* Use of supplemental oxygen totaling at least 3 L per minute or greater at baseline
* Anuria
* End-stage renal disease per KDIGO criteria
* Dialysis use
Where this trial is running
Lakeland, Florida
- Lakeland Regional Hospital — Lakeland, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Anas Bizanti, MD — Lakeland Regional Hospital
- Study coordinator: Andrew Lurie, DO
- Email: Andrew.Lurie@myLRH.org
- Phone: 8636871100
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.