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NCT Number: NCT07464249

Comparison of the Effectiveness of Different Diuretic Therapies in the Management of Acute Heart Failure

Acute decompensated heart failure (ADHF) is a clinical syndrome associated with high morbidity and mortality rates. Current guidelines emphasize the importance of oxygenation and diuresis in the management of ADHF. However, there is no clear recommendation regarding whether diuretic therapy should be administered as intermittent bolus dosing or continuous infusion. The aim of this study was to compare the early efficacy of bolus versus continuous infusion diuretic therapy in the emergency department management of ADHF. In this single-center, prospective, randomized, double-blind, parallel-group clinical trial, patients aged ≥18 years presenting with ADHF and without known chronic kidney disease were randomized in a 1:1 ratio to receive either intermittent bolus therapy or continuous infusion therapy. Allocation concealment was ensured using opaque sealed envelopes. To maintain blinding, simultaneous placebo-like administrations were performed in both groups. The primary endpoint was total urine output at 2 and 4 hours. Secondary endpoints included changes in the internal jugular vein collapsibility index (JVCI) at 2 and 4 hours. Tertiary end point was spot urinary sodium at 2 and 4 hours.

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Key information

Conditions

Acute Decompensated Heart Failure (ADHF)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sultan 2. Abdulhamid Han Research and Training Hospital

Istanbul, Turkey (Türkiye)

About this study

Acute decompensated heart failure (ADHF) is a common cause of emergency department admission and is associated with significant morbidity and mortality. Intravenous loop diuretics remain the cornerstone of treatment for patients presenting with volume overload. However, the optimal method of administration-intermittent bolus versus continuous infusion-remains controversial.

Most randomized studies comparing these strategies have been conducted in hospitalized patients and have focused on outcomes measured over longer observation periods. Data evaluating the early response to diuretic therapy in the emergency department setting are limited.

This prospective, randomized, double-blind clinical study aimed to compare the early effects of intravenous bolus versus continuous infusion furosemide therapy in patients presenting to the emergency department with acute decompensated heart failure.

Eligible patients were randomly assigned to receive either intermittent intravenous bolus furosemide or continuous infusion furosemide. Blinding was achieved by administering placebo infusion or placebo bolus according to treatment allocation. The primary outcome of the study was cumulative urine output during the first four hours after treatment initiation. Secondary outcomes included changes in the internal jugular vein collapsibility index measured by bedside ultrasound. The tertiary outcome was the spot urinary sodium at 2nd and 4th hours of study The study also evaluated the potential role of internal jugular vein collapsibility index as a dynamic and non-invasive parameter for monitoring systemic congestion during early diuretic therapy in the emergency department.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age ≥18 years
  • Established diagnosis of heart failure
  • Presentation with acute decompensation meeting AHA/ACC Stage C-D criteria
  • New York Heart Association (NYHA) Class III-IV functional status at admission

Exclusion criteria

  • Known chronic kidney disease
  • Hemodynamic instability at presentation
  • Development of advanced airway requirement during follow-up
  • Requirement for emergent dialysis

Treatment and study plan

Furosemide Bolus

Drug

atients in this group received 2.5 times their usual daily diuretic dose administered as an intravenous bolus infusion

Other names: Bolus diuretics

Furosemide Continuous İnfusion

Drug

Patients in this group received 2.5 times their usual daily diuretic dose administered as an intravenous continious infusion

Other names: continuous infusion diuretics

Primary outcomes

  1. Diuresis

    Time frame: 2nd and 4th hours after administration of Furosemide

    Total cumulative urine output

Secondary outcomes

  1. Juguler Venous Collapsibility Index Change

    Time frame: after administration of furosemide, 2nd and 4th hour

    Change from baseline in internal jugular vein collapsibility index (JVCI) at 2 and 4 hours, measured by bedside ultrasonography.

Other outcomes

  1. Spot Urinary Sodium

    Time frame: 2 hours and 4 hours after Furosemide administration

    Spot urine sodium concentration measured after initiation of diuretic therapy to evaluate early natriuretic response.

Sponsors and collaborators

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Other

Registry information

Official study title

Comparison of the Effectiveness of Bolus and Infusion Diuretic Therapy in the Management of Acute Heart Failure in Emergency Departments: a Randomised, Double-blind Clinical Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

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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