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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Furosemide intravenous solution
  Diuretics will be titrated to achieve a urine sodium concentration of 50 mmol/L
• Препарат Furosemide intravenous solution
  Diuretics will be titrated to achieve a urine sodium concentration of 85 mmol/L
• Препарат Furosemide intravenous solution
  Standard of care

Первичные конечные точки

• Natriuresis at 24 hours [Срок оценки: 24 hours]

Вторичные конечные точки (10)

• Natriuresis at 48 hours [Срок оценки: 48 hours after enrollment in trial]
• Diuresis at 24 hours [Срок оценки: 24 hours after enrollment]
• Diuresis at 48 hours [Срок оценки: 48 hours after enrollment]
• Length of Stay [Срок оценки: 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 [Срок оценки: 30 days after discharge]
• Readmission rate of any cause at 90 days [Срок оценки: 90 days after the time of discharge]
• Readmission rate of Heart failure [Срок оценки: 30 days]
• Readmission rate for heart failure [Срок оценки: 90 days]
• Weight change [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Lakeland Regional Hospital — Lakeland

Идентификаторы

NCT: NCT07263035 · 2025_001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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