Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Lakeland Regional Health Systems, Inc.
- Enrollment
- 600
- Locations
- 2
- Primary Endpoint
- Natriuresis at 24 hours
Overview
Brief Summary
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:
- Does targeting a higher urine sodium goal achieve greater natriuresis and diuresis?
- Does targeting a higher urine sodium goal reduce frequency of hospital readmissions?
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •End-stage renal disease per KDIGO criteria
- •Dialysis use
Arms & Interventions
50 mmol/L urine sodium
Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L
Intervention: Furosemide intravenous solution (Drug)
Control
Traditional diuretic dosing adjustment per provider
Intervention: Furosemide intravenous solution (Drug)
85 mmol/L urine sodium
Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L
Intervention: Furosemide intravenous solution (Drug)
Outcomes
Primary Outcomes
Natriuresis at 24 hours
Time Frame: 24 hours
24-hour natriuresis as measured by urine sodium in a 24-hour urine collection
Secondary Outcomes
- Natriuresis at 48 hours(48 hours after enrollment in trial)
- Diuresis at 24 hours(24 hours after enrollment)
- Length of Stay(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.)
- Diuresis at 48 hours(48 hours after enrollment)
- Readmission rate of any cause at 90 days(90 days after the time of discharge)
- Readmission rate of Heart failure(30 days)
- Readmission rate for heart failure(90 days)
- Weight change(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.)
- Readmission of any cause at 30 days(30 days after discharge)
- Net fluid balance(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.)
Investigators
Anas Bizanti, MD
Associate Program Director, Internal Medicine Residency - Principal Investigator
Lakeland Regional Health Systems, Inc.