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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
600
Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L
Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L
Standard of care
Lakeland Regional Hospital
Lakeland, Florida, United States
RECRUITINGNatriuresis at 24 hours
24-hour natriuresis as measured by urine sodium in a 24-hour urine collection
Time frame: 24 hours
Natriuresis at 48 hours
Total urine sodium assessed by 24-hour urine collection
Time frame: 48 hours after enrollment in trial
Diuresis at 24 hours
Total urine volume assessed by 24 hour collection
Time frame: 24 hours after enrollment
Diuresis at 48 hours
Total urine volume assessed via 24-hour collection
Time frame: 48 hours after enrollment
Length of Stay
Duration of hospitalization
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
Proportion of participants who experience an unplanned hospital readmission for any cause within 30 days after the index hospital discharge.
Time frame: 30 days after discharge
Readmission rate of any cause at 90 days
Proportion of participants who experience an unplanned hospital readmission for any cause within 90 days after the index hospital discharge.
Time frame: 90 days after the time of discharge
Readmission rate of Heart failure
Proportion of participants who experience an unplanned hospital readmission specifically for heart failure within 30 days after the index hospital discharge.
Time frame: 30 days
Readmission rate for heart failure
Proportion of participants who experience an unplanned hospital readmission specifically for heart failure within 90 days after the index hospital discharge.
Time frame: 90 days
Weight change
Difference in weight from admission compared to discharge
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
Cumulative difference between total fluid intake and output during the hospitalization
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.
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