Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Furosemide intravenous solution, Furosemide intravenous solution, Furosemide intravenous solution.
- Who it may be relevant to
- Registry conditions: Heart Failure, Heart Failure - NYHA II - IV, Heart Failure Acute, Acute Heart Failure (AHF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The goal of this clinical trial is to learn if increasing the dose of diuretics to achieve a higher urine sodium target produces better clinical results when treating patients hospitalized with acute heart failure when compared to lower urine sodium target and standard of care. The main questions it aims to answer are: 1. Does targeting a higher urine sodium goal achieve greater natriuresis and diuresis? 2. Does targeting a higher urine sodium goal reduce frequency of hospital readmissions? 3. Does targeting a higher urine sodium goal reduce hospital length of stay? Researchers will compare natriuresis-guided arms with standard of care to see if targeting higher natriuresis goals improves significantly over current practice. Participants will submit urine samples at routine intervals after being given diuretics to evaluate urine sodium concentration. If urine sodium is low then diuretic dose will be increased.
Detailed description
Patients will be randomized into one of three groups: 50 micromolar natriuresis, 85 micromolar natriuresis, and standard of care. The natriuresis arms will have urine sodium assessed two to four hours administration of intravenous diuretics. If the natriuretic response is inadequate they will immediately receive a higher dose of diuretic. This process will be repeated for the first 72 hours of admission.
Interventions
- Drug Furosemide intravenous solution
Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L - Drug Furosemide intravenous solution
Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L - Drug Furosemide intravenous solution
Standard of care
Primary outcome measures
- Natriuresis at 24 hours [Time frame: 24 hours]
Secondary outcome measures (10)
- Natriuresis at 48 hours [Time frame: 48 hours after enrollment in trial]
- Diuresis at 24 hours [Time frame: 24 hours after enrollment]
- Diuresis at 48 hours [Time frame: 48 hours after enrollment]
- Length of Stay [Time frame: From the date and time of admission order until the date and time of discharge order, assessed for each participant up to 30 days after admission or death from any cause, whichever comes first.]
- Readmission of any cause at 30 days [Time frame: 30 days after discharge]
- Readmission rate of any cause at 90 days [Time frame: 90 days after the time of discharge]
- Readmission rate of Heart failure [Time frame: 30 days]
- Readmission rate for heart failure [Time frame: 90 days]
- Weight change [Time frame: Weight assessed at baseline within 24 hours of hospital admission and at discharge, with the discharge weight measured on the discharge day up to 30 days after admission.]
- Net fluid balance [Time frame: Net fluid balance assessed from baseline Day 1 of admission through hospital discharge, with discharge assessment on the discharge day up to 30 days after admission.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Lakeland Regional Hospital — Lakeland
Identifiers
NCT: NCT07263035 · 2025_001