Acute Decompensated Heart Failure
Conditions
Keywords
Heart Failure, Dopamine, Furosemide, Worsening Renal Function, Hypokalemia, Outcomes, Prognosis
Brief summary
The aim of this study is to compare the effects of 1) high-dose furosemide, 2) low-dose furosemide, and 3) low-dose furosemide combined with low-dose dopamine on diuresis, clinical status, renal function, electrolyte balance, length of stay, and 60-day post-discharge outcomes in patients hospitalized with acute decompensated heart failure.
Detailed description
The aim of this study is to compare the effects of: 1. high-dose furosemide (HDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 20 mg/h for a total of 8 hours), 2. low-dose furosemide (LDF, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide for a total of 8 hours), and 3. low-dose furosemide combined with low-dose dopamine (LDFD, 40 mg furosemide bolus IV, followed by continuous IV infusion of 5 mg/h furosemide plus 5μg/kg/min dopamine for a total of 8 hours) on diuresis, perceived dyspnea, renal function, electrolyte balance, total length of stay, and 60-day post-discharge outcomes in patients hospitalized with ADHF.
Interventions
DRUGHigh-dose furosemide
High-dose furosemide (HDF): 20 mg/h continuous IV administration for 8 hours
DRUGLow-dose furosemide
Low-dose furosemide (LDF): continuous IV administration of 5 mg/h furosemide
DRUGLow-dose furosemide combined with low-dose dopamine
Low-dose furosemide combined with low-dose dopamine (LDFD): continuous IV administration of 5 mg/h furosemide combined with 5 μg/kg/min dopamine for a total of 8 hours
Sponsors
Larissa University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with New York Heart Association (NYHA) functional class IV heart failure according to the American Heart Association (AHA) classification, namely dyspnea on minimal exertion or rest dyspnea, orthopnea, and paroxysmal nocturnal dyspnea, * signs of congestion (third heart sound or pulmonary rales on physical examination), * pulmonary congestion on chest x-ray, * serum B-type natriuretic peptide levels \> 400 pg/ml or NT-proBNP \> 1500 pg/ml, * echocardiographic documentation of systolic or diastolic dysfunction, * age \>18 years old, * on medical therapy with an ACE-inhibitor and/or a β-blocker, * experiencing an acute decompensation of known chronic HF, * baseline oxygen saturation \<90% on admission arterial blood gas
Exclusion criteria
* acute de novo HF; * severe renal failure (serum creatinine \>200 μmol/L or GFR \<30 ml/min/1.73m2) * admission systolic blood pressure \<90 mm Hg; * severe valvular disease; * known adverse reactions to furosemide or dopamine; * HF secondary to congenital heart disease; * a scheduled procedure with a need for IV contrast dye; * a scheduled cardiac surgery within 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1-year mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure). | 1-year |
Secondary
| Measure | Time frame |
|---|---|
| 60-day mortality or rehospitalization (all-cause, cardiovascular, non-cardiovascular, and due to worsening heart failure). | 60-day post discharge |
| Novel indices of acute renal ischemia/injury (cystatin-C, KIM-1, NGAL) | Throughout hospitalization |
Countries
Greece, United States
Outcome results
None listed