Diuretic Treatment in High Risk Decompensated Advanced Heart Failure. Bolus Intermittent Versus Continuous Infusion of Furosemide: a Randomized Controlled Trial.
Overview
- Phase
- Phase 3
- Intervention
- Loop Diuretics
- Conditions
- Heart Failure NYHA Class III
- Sponsor
- University of Turin, Italy
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Freedom from congestion
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Loop diuretics are the main therapy for decongestion of patients with advanced acute heart failure. However, these patients often develop diuretic-resistance or even diuretic-refractoriness. In order to overcome such resistance to diuretic, the clinician can increase the dose of furosemide, or change the way of administration (continuous infusion versus boluses) or associate a different class of diuretics (thiazide diuretics, K+-sparing diuretics) up to the addition of low doses of inotropic agents to improve renal perfusion. At the present time there is no evidence in literature in advanced acute heart failure patients about the superiority of the treatment with furosemide in continuous infusion or in intermittent boluses. The aim of the study was to evaluate the efficacy of furosemide in boluses versus continuous infusion in advanced acute heart failure.
Investigators
Simone Frea
MD, Cardiologist
University of Turin, Italy
Eligibility Criteria
Inclusion Criteria
- •Advanced heart failure
- •Systolic blood pressure ≤ 110 mmHg
- •Serum sodium ≤ 135 mEq/L
- •Left systolic ventricular insufficiency (FE \< 35%) note for at least 6 months
- •Class NYHA III-IV despite medical treatment maximal
Exclusion Criteria
- •Acute coronary syndrome
- •Shock cardiogenic
- •Chronic renal failure stage V
Arms & Interventions
Continuous infusion of loop diuretics
Furosemide continuous infusion: 125 or 250 mg die
Intervention: Loop Diuretics
Intermittent infusion of loop diuretics
Furosemide bolus intermittent: 125 or 250 mg die
Intervention: Loop Diuretics
Outcomes
Primary Outcomes
Freedom from congestion
Time Frame: 72 hours after randomization
Secondary Outcomes
- Change in body weight(72 hours after randomization)
- Treatment failure(72 hours after randomization)
- Weight differences based on diuretic dose unity(72 hours after randomization)
- Worsening of renal function(72 hours after randomization)
- Worsening or persistent HF at 72 h(72 hours after randomization)
- Laboratory data variations in NTproBNP(72 hours after randomization)