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

University of Turin

Status and phase: Completed; Phase 3

Conditions: Heart Failure NYHA Class IV; Heart Failure NYHA Class III

Treatments: Drug: Loop Diuretics

Study type: Interventional

Funder types: Other

Identifiers

NCT03592836

DRAIN trial

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Continuous infusion of loop diuretics

Active Comparator group

Description:

Furosemide continuous infusion: 125 or 250 mg die

Treatment:

Drug: Loop Diuretics

Intermittent infusion of loop diuretics

Active Comparator group

Description:

Furosemide bolus intermittent: 125 or 250 mg die

Treatment:

Drug: Loop Diuretics