Readily Available Urinary Sodium Analysis in Patients With Acute Decompensated Heart Failure

Not Applicable

Completed

• Conditions: Acute Decompensated Heart Failure
• Interventions: Procedure: Standard of Care; Procedure: Diuretic protocol

• Registration Number: NCT06278792
• Lead Sponsor: Ziekenhuis Oost-Limburg

Brief Summary

The goal of this clinical trial is to compare physician-guided (SOC) versus nurse-led natriuresis-guided diuretic therapy in patients with acute decompensated heart failure (ADHF). The main questions it aims to answer are:

* difference in natriuresis and diuresis

* feasibility of the protocol.

Participants will be asked to gather two 24 h urine collections.

Researchers will compare SOC versus nurse-led diuretic titration to see if there is a difference in natriuresis after 48 hours.

Detailed Description

The EASY-HF study was a single-centre, randomized, open-label study comparing standard of care (SOC) diuretic management at the treating physician's discretion with a nurse-led natriuresis-guided protocol in patients with ADHF. A bedside sensor was used to measure the urinary sodium content.The primary endpoint was total natriuresis after 48 hours. Secondary endpoints included safety profile and user-friendliness of both the protocol and the point-of-care sensor.

Study Timeline

• Study Start: 2022-03-07
• Primary Completion: 2023-07-12
• Study Completion: 2024-01-05
• Status Verified: 2024-02
• Study First Submitted: 2024-02-08
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-26
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Older than 18 years
• Provide written informed consent
• Hospital admission with signs and symptoms of congestion warranting intravenous decongestive therapy
• Congestion score of at least 2 based upon the presence of edema, pleural effusion, or ascites
• N-terminal pro-B-type natriuretic peptide (NT-proBNP) level of at least 500 ng per litre (800 ng per litre in case of atrial fibrillation)

Exclusion Criteria

• Patients unable to collect a 48h-urine collection
• Estimated GFR below 20 ml/min/1.73m^2
• Concomitant diagnosis of an acute coronary syndrome
• Need for inotropic or vasopressor support
• Ventricular assist device
• Renal replacement therapy
• Treatment with intravenous loop diuretics > 80mg furosemide or an equivalence of another loop diuretic (40mg furosemide = 1mg bumetanide) during the index hospitalization and prior to randomization

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	48 hour diuretic management at the treating physician's discretion
Intervention	Diuretic protocol	48-hour nurse-led natriuresis-guided protocol

Primary Outcome Measures

Name	Time	Method
Urinary sodium excretion after 48 hours	48 hours	Total natriuresis after 48 hours (mmol)

Secondary Outcome Measures

Name	Time	Method
Urinary sodium excretion on daily base	24 hours	Total natriuresis (mmol) during the first and second 24 h
Achievement of decongestion	48 hours	Congestion score of no more than trace edema (score \< 2) after 48 hours of diuretic treatment. Minimum score 0 (decongested), maximum score 10 (severe congested)
Urinary output after 48 hours	48 hours	Total diuresis after 48 hours (ml)
Urinary output on daily base	24 hours	Total diuresis during the first and second 24 h

Trial Locations

Locations (1)

Ziekenhuis Oost-Limburg AV; 🇧🇪 Genk, Limburg, Belgium