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

Primary Purpose

Heart Failure NYHA Class III, Heart Failure NYHA Class IV

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Loop Diuretics
Sponsored by
University of Turin, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure NYHA Class III

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Simone Frea

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Continuous infusion of loop diuretics

Intermittent infusion of loop diuretics

Arm Description

Furosemide continuous infusion: 125 or 250 mg die

Furosemide bolus intermittent: 125 or 250 mg die

Outcomes

Primary Outcome Measures

Freedom from congestion

Secondary Outcome Measures

Worsening of renal function
Increase in creatinine value > 0.3 mg/dl or increase > 1.5 times
Worsening or persistent HF at 72 h
Need to increase the dose of inotropes or diuretics
Change in body weight
Laboratory data variations in NTproBNP
Treatment failure
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

Full Information

First Posted
June 18, 2018
Last Updated
July 9, 2018
Sponsor
University of Turin, Italy
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1. Study Identification

Unique Protocol Identification Number
NCT03592836
Brief Title
Diuretic Response in Advanced Heart Failure: Bolus Intermittent vs Continuous INfusion
Acronym
DRAIN
Official Title
Diuretic Treatment in High Risk Decompensated Advanced Heart Failure. Bolus Intermittent Versus Continuous Infusion of Furosemide: a Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2013 (Actual)
Primary Completion Date
December 22, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure NYHA Class III, Heart Failure NYHA Class IV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous infusion of loop diuretics
Arm Type
Active Comparator
Arm Description
Furosemide continuous infusion: 125 or 250 mg die
Arm Title
Intermittent infusion of loop diuretics
Arm Type
Active Comparator
Arm Description
Furosemide bolus intermittent: 125 or 250 mg die
Intervention Type
Drug
Intervention Name(s)
Loop Diuretics
Other Intervention Name(s)
furosemide
Intervention Description
intravenous administration of diuretics
Primary Outcome Measure Information:
Title
Freedom from congestion
Time Frame
72 hours after randomization
Secondary Outcome Measure Information:
Title
Worsening of renal function
Description
Increase in creatinine value > 0.3 mg/dl or increase > 1.5 times
Time Frame
72 hours after randomization
Title
Worsening or persistent HF at 72 h
Description
Need to increase the dose of inotropes or diuretics
Time Frame
72 hours after randomization
Title
Change in body weight
Time Frame
72 hours after randomization
Title
Laboratory data variations in NTproBNP
Time Frame
72 hours after randomization
Title
Treatment failure
Description
Composed by the following events: persistence of congestion, need to increase diuretic treatment, need of renal replacement treatment
Time Frame
72 hours after randomization
Title
Weight differences based on diuretic dose unity
Time Frame
72 hours after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simone Frea, MD
Organizational Affiliation
A.O.U. Città della Salute e della Scienza di Torino
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simone Frea
City
Torino
State/Province
To
ZIP/Postal Code
10126
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
31256261
Citation
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.
Results Reference
derived

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

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