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

Heart Failure NYHA Class III Clinical Trial

— DRAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592836
• Other study ID #: DRAIN trial
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2013
• Est. completion date: December 22, 2017

Study information

• Verified date: July 2018
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 22, 2017
• Est. primary completion date: December 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure NYHA Class III
• Heart Failure NYHA Class IV

Intervention

Drug:
• Loop Diuretics
intravenous administration of diuretics

Locations

Country	Name	City	State
Italy	Simone Frea	Torino	To

Sponsors (1)

Lead Sponsor	Collaborator
University of Turin, Italy

Country where clinical trial is conducted

Italy, 

Outcome

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