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

Acute Decompensated Heart Failure Clinical Trial

— EASY-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06278792
• Other study ID #: Z-2021104
• Status: Completed
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: January 5, 2024

Study information

• Verified date: February 2024
• Source: Ziekenhuis Oost-Limburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 5, 2024
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

Procedure:
• Diuretic protocol
Nurse-led natriuresis-guided protocol based on a bedside urinary sodium result
• Standard of Care
Diuretic therapy at the discretion of the physician

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg AV	Genk	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg	Fund for Scientific Research, Flanders, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diuretic dose	Dose of loop diuretics and other diuretic agents administered	48 hours
Other	User-friendliness device and protocol	Questionnaire for the nursing staff with regard to user-friendliness of device and diuretic protocol (1 (totally disagree) to 10 (completely agree))	180 days
Other	Weight	Body weight change	48 hours
Other	Number of participants with need for heart failure rehospitalization	Heart failure rehospitalization during the first 180 after start of the study	180 days
Other	Rate of all-cause mortality	All-cause mortality during the first 180 after start of the study	180 days
Other	Length of hospital stay	The time frame between hospital admission and discharge will be calculated	180 days
Other	Number of participants with severe hypotension	systolic blood pressure below 85mmHg	48 hours
Other	Number of participants with abnormal blood parameters	Any abnormal laboratory parameters in the blood (electrolytes, renal function) during a 3 day follow-up will be reported	3-day follow-up
Primary	Urinary sodium excretion after 48 hours	Total natriuresis after 48 hours (mmol)	48 hours
Secondary	Urinary output after 48 hours	Total diuresis after 48 hours (ml)	48 hours
Secondary	Urinary sodium excretion on daily base	Total natriuresis (mmol) during the first and second 24 h	24 hours
Secondary	Urinary output on daily base	Total diuresis during the first and second 24 h	24 hours
Secondary	Achievement of decongestion	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)	48 hours