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

NCT ID: NCT03592836

Last Updated: 2018-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-01

Study Completion Date

2017-12-22

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.

Detailed Description

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Conditions

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Heart Failure NYHA Class III Heart Failure NYHA Class IV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Continuous infusion of loop diuretics

Furosemide continuous infusion: 125 or 250 mg die

Group Type ACTIVE_COMPARATOR

Loop Diuretics

Intervention Type DRUG

intravenous administration of diuretics

Intermittent infusion of loop diuretics

Furosemide bolus intermittent: 125 or 250 mg die

Group Type ACTIVE_COMPARATOR

Loop Diuretics

Intervention Type DRUG

intravenous administration of diuretics

Interventions

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Loop Diuretics

intravenous administration of diuretics

Intervention Type DRUG

Other Intervention Names

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furosemide

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Simone Frea

MD, Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Simone Frea, MD

Role: PRINCIPAL_INVESTIGATOR

A.O.U. Città della Salute e della Scienza di Torino

Locations

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Simone Frea

Torino, To, Italy

Site Status

Countries

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Italy

References

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Frea S, Pidello S, Volpe A, Canavosio FG, Galluzzo A, Bovolo V, Camarda A, Golzio PG, D'Ascenzo F, Bergerone S, Rinaldi M, Gaita F. Diuretic treatment in high-risk acute decompensation of advanced chronic heart failure-bolus intermittent vs. continuous infusion of furosemide: a randomized controlled trial. Clin Res Cardiol. 2020 Apr;109(4):417-425. doi: 10.1007/s00392-019-01521-y. Epub 2019 Jun 29.

Reference Type DERIVED
PMID: 31256261 (View on PubMed)

Other Identifiers

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DRAIN trial

Identifier Type: -

Identifier Source: org_study_id

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