DiurHF is a prospective, multicenter, observational, study that compares continuous with intermittent infusion of furosemide in patients admitted with a diagnosis of ADHF. Previous pilot study design was planned to anticipate a larger multicenter trial able to definitively evaluate the optimal loop diuretic use strategy in patients with ADHF.
The use of intravenous loop diuretics is a cornerstone of therapy for acutely decompensated heart failure (ADHF); significant concerns have been raised regarding risks and benefits of loop diuretics, particularly about dosage and administration regimen. Recent guidelines recommend the use of these drugs to reduce left ventricular filling pressure, avoid pulmonary edema, and alleviate peripheral fluid retention. Some studies have provided guidelines for the administration of these drugs in clinical practice, but data interpretation remains challenging due to the frequent exclusion of patients with kidney disease from major ADHF clinical trials. Therefore, it is not clear if continuous infusion is better than intermittent boluses in terms of decongestion, maintenance of renal filtration function and prognosis. On the other hand, continuous administration should provide a more constant delivery of the drug into the tubule, potentially reducing these phenomena. The aim of the study is to evaluate the better loop diuretic intravenous administration in terms of renal function, congestion signs, BNP and outcome.
Study Type
OBSERVATIONAL
Enrollment
370
Intravenous continuous Furosemide infusion
Intravenous bolus intermittent Furosemide Infusion
Ospedale Madonna della Navicella
Chioggia, Venezia, Italy
RECRUITINGAzienda Ospedaliera di Padova
Padua, Italy
RECRUITINGUniversity of Rome La Sapienza
Roma, Italy
RECRUITINGCardiac death and rehospitalization for HF
Number of participant who are affected by cardiovascular death or rehospitalization within 180 days from discharge.
Time frame: 180 days
length of hospital stay (days)
evaluation of length of hospital stay (days) in the two groups
Time frame: From date of randomization until the discharge (7-12 days)
Inotropes agents
Need to use inotropes agents during the treatment
Time frame: From date of randomization until the discharge (7-12 days)
hypertonic saline solution
need to use hypertonic saline solution during the treatment
Time frame: From date of randomization until the discharge (7-12 days)
Acute kidney injury
changes of renal function in terms of creatinine and estimated glomerular filtration rate (eGFR) comparing continuous vs intermittent administration
Time frame: From date of randomization until the discharge (7-12 days)
Body weight changes
Body weight changes in two groups from the admission to discharge
Time frame: from admission to discharge (7-12 days)
Diuresis
mean urine output in two groups from the admission to discharge
Time frame: from admission to discharge (7-12 days)
BNP changes
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Department of Internal Medicine, Cardiovascular Diseases Unit
Siena, Italy
RECRUITINGmean paired changes of B-type natriuretic peptide (BNP) in the two groups during hospitalization.
Time frame: From date of randomization until the discharge (7-12 days)
BUN changes
mean paired changes of blood urea nitrogen (BUN) in the two groups during hospitalization.
Time frame: From date of randomization until the discharge (7-12 days)
Reduction of edema
Evaluation of edema regression (or not) after treatment in the two groups.
Time frame: From date of randomization until the discharge (7-12 days)
Reduction of dyspnea
Evaluation of dyspnea scale reduction (or not) after treatment in the two groups.
Time frame: From date of randomization until the discharge (7-12 days)
Regression of pulmonary congestion
Evaluation of pulmonary congestion regression (or not) after treatment in the two groups, considering Chest X-ray at admission and at discharge
Time frame: From date of randomization
Diuretic efficiency: (Weight loss/days of infusion)/ (Mean daily furosemide dosage/40 mg of furosemide)
Evaluation of persistence of congestion (or not) and incidence of AKI (or not) according to quartiles of diuretic efficiency.
Time frame: From hospital admission until the discharge (7-12 days)
High (> 125 mg/die) versus low (<125 mg/die) intravenous diuretic dosage
Number of patients with high in-hospital diuretic dosage who were affected by adverse outcome.
Time frame: 180 days
Diuretic efficiency: (Weight loss/days of infusion)/ (Mean daily furosemide dosage/40 mg of furosemide)
Number of patients (according quartiles of diuretic efficiency) who were affected by adverse outcome.
Time frame: 180 days