Phase 4 N=57 Randomized Double-blind Treatment

Loop Diuretics Administration and Acute Heart Failure

Acute Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT01441245 ↗

Enrolled (actual)

Serious AEs

40.4%

Results posted

Feb 2016

Primary outcome: Primary: Evaluation of Mean Urine Output Volume During the Infusion Period — 2505; 2140 mL — p=0.04

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: furosemide infusion (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Siena
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Evaluation of Mean Urine Output Volume During the Infusion Period	2505; 2140	0.04 sig
PRIMARY Evaluation of Renal Function in Terms of Creatinine Levels at Discharge	1.78; 1.51	0.01 sig
PRIMARY Evaluation of Renal Function in Terms of Changes in Creatinine Levels	-0.10; -0.50	0.02 sig
PRIMARY Evaluation of B-type Natriuretic Peptide (BNP) Levels From Admission to the End of Treatment	679; 949	0.04 sig
PRIMARY Change in Brain Natriuretic Peptide (BNP) Levels From Admission to the Discharge	-525; -148	0.03 sig
PRIMARY Evaluation of Renal Function in Terms of Changes in GFR	-3.18; -1.93	0.01 sig
PRIMARY Evaluation of Renal Function in Terms of GFR Values at Discharge	44.8; 46.7	0.05
SECONDARY Length of Hospitalization in the Two Groups	80; 44	<0.01 sig
SECONDARY Dopamine Infusion During Hospitalization	50; 26	<0.01 sig

Summary

Intravenous loop diuretics is the therapy most commonly used to treat pulmonary congestion and systemic fluid overload. In theory, continuous infusion should allow for a more consistent diuresis, avoiding the sodium reabsorption in the distal tubule as well as the neurohormonal activation. This should lead to renal function improvement and BNP decrease.

Eligibility Criteria

Inclusion Criteria

Patients took part in the random sample selection if they met the diagnostic criteria for acute decompensated HF.
Patients with primary diagnosis of ADHF, volume overload with cardia dilation and LVEF 100 pg/ml.

Exclusion Criteria

Patients were excluded if they had received more than 2 IV doses of furosemide or any continuous infusion of furosemide 1 month before randomization
If they had end-stage renal disease or the need for renal replacement therapy, isolated diastolic dysfunction.
Recent myocardial infarction

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Data sourced from ClinicalTrials.gov (NCT01441245). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.