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OpenTrials
Completed

NCT Number: NCT03592836

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

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.

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Key information

Conditions

Heart Failure NYHA Class III Heart Failure NYHA Class IV

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Simone Frea

Torino, To, 10126, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Loop Diuretics

Drug

intravenous administration of diuretics

Other names: furosemide

Primary outcomes

  1. Freedom from congestion

    Time frame: 72 hours after randomization

Secondary outcomes

  1. Worsening of renal function

    Time frame: 72 hours after randomization

    Increase in creatinine value > 0.3 mg/dl or increase > 1.5 times

  2. Worsening or persistent HF at 72 h

    Time frame: 72 hours after randomization

    Need to increase the dose of inotropes or diuretics

  3. Change in body weight

    Time frame: 72 hours after randomization

  4. Laboratory data variations in NTproBNP

    Time frame: 72 hours after randomization

  5. Treatment failure

    Time frame: 72 hours after randomization

    Composed by the following events: persistence of congestion, need to increase diuretic treatment, need of renal replacement treatment

  6. Weight differences based on diuretic dose unity

    Time frame: 72 hours after randomization

Sponsors and collaborators

Lead sponsor

University of Turin, Italy

Other

Registry information

Official study title

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

Acronym: DRAIN

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2018
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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