Acute Decompensated Heart Failure
Conditions
Keywords
acute decompensated heart failure, natriuresis, nurse-led, diuretic therapy
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.
Interventions
PROCEDUREDiuretic protocol
Nurse-led natriuresis-guided protocol based on a bedside urinary sodium result
PROCEDUREStandard of Care
Diuretic therapy at the discretion of the physician
Sponsors
Fund for Scientific Research, Flanders, Belgium
Ziekenhuis Oost-Limburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
All physicians were blinded for the spot urinary sodium measurements. Additionally, while urine was collected for the first 48 h in both groups, the analysis was only performed afterwards.
Intervention model 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary sodium excretion after 48 hours | 48 hours | Total natriuresis after 48 hours (mmol) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary output after 48 hours | 48 hours | Total diuresis after 48 hours (ml) |
| Urinary sodium excretion on daily base | 24 hours | Total natriuresis (mmol) during the first and second 24 h |
| Urinary output on daily base | 24 hours | Total diuresis 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | 180 days | The time frame between hospital admission and discharge will be calculated |
| Diuretic dose | 48 hours | Dose of loop diuretics and other diuretic agents administered |
| Number of participants with abnormal blood parameters | 3-day follow-up | Any abnormal laboratory parameters in the blood (electrolytes, renal function) during a 3 day follow-up will be reported |
| Number of participants with severe hypotension | 48 hours | systolic blood pressure below 85mmHg |
| User-friendliness device and protocol | 180 days | Questionnaire for the nursing staff with regard to user-friendliness of device and diuretic protocol (1 (totally disagree) to 10 (completely agree)) |
| Weight | 48 hours | Body weight change |
| Number of participants with need for heart failure rehospitalization | 180 days | Heart failure rehospitalization during the first 180 after start of the study |
| Rate of all-cause mortality | 180 days | All-cause mortality during the first 180 after start of the study |
Countries
Belgium
Outcome results
None listed