Diuretic Response in Advanced Heart Failure: Bolus Intermittent vs Continuous INfusion

Study Overview
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Brief Summary
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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.

Official Title
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Diuretic Treatment in High Risk Decompensated Advanced Heart Failure. Bolus Intermittent Versus Continuous Infusion of Furosemide: a Randomized Controlled Trial.

Conditions
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Heart Failure NYHA Class III, Heart Failure NYHA Class IV

Intervention / Treatment
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* Drug: Loop Diuretics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced heart failure WET ≥ 12 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous infusion of loop diuretics<br>Furosemide continuous infusion: 125 or 250 mg die | Drug: Loop Diuretics<br>* intravenous administration of diuretics<br>* Other names: furosemide;|
| Active Comparator: Intermittent infusion of loop diuretics<br>Furosemide bolus intermittent: 125 or 250 mg die | Drug: Loop Diuretics<br>* intravenous administration of diuretics<br>* Other names: furosemide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from congestion |  | 72 hours after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worsening of renal function | Increase in creatinine value > 0.3 mg/dl or increase > 1.5 times | 72 hours after randomization | 
| Worsening or persistent HF at 72 h | Need to increase the dose of inotropes or diuretics | 72 hours after randomization | 
| Change in body weight |  | 72 hours after randomization | 
| Laboratory data variations in NTproBNP |  | 72 hours after randomization | 
| Treatment failure | Composed by the following events: persistence of congestion, need to increase diuretic treatment, need of renal replacement treatment | 72 hours after randomization | 
| Weight differences based on diuretic dose unity |  | 72 hours after randomization |