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| Name | Class |
|---|---|
| Fund for Scientific Research, Flanders, Belgium | OTHER |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | 48 hour diuretic management at the treating physician's discretion |
|
| Intervention | Experimental | 48-hour nurse-led natriuresis-guided protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diuretic protocol | Procedure | Nurse-led natriuresis-guided protocol based on a bedside urinary sodium result |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary sodium excretion after 48 hours | Total natriuresis after 48 hours (mmol) | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary output after 48 hours | Total diuresis after 48 hours (ml) | 48 hours |
| Urinary sodium excretion on daily base | Total natriuresis (mmol) during the first and second 24 h |
| Measure | Description | Time Frame |
|---|---|---|
| Diuretic dose | Dose of loop diuretics and other diuretic agents administered | 48 hours |
| 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)) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried Mullens, MD PhD | Ziekenhuis Oost-Limburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg AV | Genk | Limburg | 3600 | Belgium |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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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.
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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.
| Standard of Care | Procedure | Diuretic therapy at the discretion of the physician |
|
| 24 hours |
| Urinary output on daily base | Total diuresis during the first and second 24 h | 24 hours |
| 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 |
| 180 days |
| Weight | Body weight change | 48 hours |
| Number of participants with need for heart failure rehospitalization | Heart failure rehospitalization during the first 180 after start of the study | 180 days |
| Rate of all-cause mortality | All-cause mortality during the first 180 after start of the study | 180 days |
| Length of hospital stay | The time frame between hospital admission and discharge will be calculated | 180 days |
| Number of participants with severe hypotension | systolic blood pressure below 85mmHg | 48 hours |
| 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 |