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

Phase 3

Completed

• Conditions: Heart Failure NYHA Class III; Heart Failure NYHA Class IV
• Interventions: Drug: Loop Diuretics

• Registration Number: NCT03592836
• Lead Sponsor: University of Turin, Italy

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-01
• Primary Completion: 2017-12-22
• Study Completion: 2017-12-22
• Study First Submitted: 2018-06-18
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-09
• Last Update Submitted: 2018-07-09
• Study First Posted: 2018-07-19
• Last Update Posted: 2018-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous infusion of loop diuretics	Loop Diuretics	Furosemide continuous infusion: 125 or 250 mg die
Intermittent infusion of loop diuretics	Loop Diuretics	Furosemide bolus intermittent: 125 or 250 mg die

Primary Outcome Measures

Name	Time	Method
Freedom from congestion	72 hours after randomization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Simone Frea; 🇮🇹 Torino, To, Italy