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

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

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.

Study Overview

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey (Türkiye)
        • Sultan 2. Abdulhamid Han Research and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bolus Group
Patients in this group received an intravenous bolus equivalent to 2.5 times their total daily oral diuretic dose in 10mL syringe. Blinding was ensured by administering 100 mL of intravenous continuous infusion normal saline as a placebo.
atients in this group received 2.5 times their usual daily diuretic dose administered as an intravenous bolus infusion
Other Names:
  • Bolus diuretics
Experimental: İnfusion Group
Patients in this group received an intravenous continious infusion equivalent to 2.5 times their total daily oral diuretic dose in 100mL saline bag. Blinding was ensured by administering 10 mL syringe of intravenous bolus normal saline as a placebo.
Patients in this group received 2.5 times their usual daily diuretic dose administered as an intravenous continious infusion
Other Names:
  • continuous infusion diuretics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diuresis
Time Frame: 2nd and 4th hours after administration of Furosemide
Total cumulative urine output
2nd and 4th hours after administration of Furosemide

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
after administration of furosemide, 2nd and 4th hour

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 hours and 4 hours after Furosemide administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 3, 2024

Primary Completion (Actual)

September 30, 2024

Study Completion (Actual)

September 30, 2024

Study Registration Dates

First Submitted

March 6, 2026

First Submitted That Met QC Criteria

March 6, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol will be shared but Our clinical datas' are not available for sharig considering ethical problems.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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