- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07464249
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Sultan 2. Abdulhamid Han Research and Training Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
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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.
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atients in this group received 2.5 times their usual daily diuretic dose administered as an intravenous bolus infusion
Other Names:
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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.
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Patients in this group received 2.5 times their usual daily diuretic dose administered as an intravenous continious infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diuresis
Time Frame: 2nd and 4th hours after administration of Furosemide
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Total cumulative urine output
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2nd and 4th hours after administration of Furosemide
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Juguler Venous Collapsibility Index Change
Time Frame: after administration of furosemide, 2nd and 4th hour
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Change from baseline in internal jugular vein collapsibility index (JVCI) at 2 and 4 hours, measured by bedside ultrasonography.
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after administration of furosemide, 2nd and 4th hour
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Spot Urinary Sodium
Time Frame: 2 hours and 4 hours after Furosemide administration
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Spot urine sodium concentration measured after initiation of diuretic therapy to evaluate early natriuretic response.
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2 hours and 4 hours after Furosemide administration
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Collaborators and Investigators
Publications and helpful links
General Publications
- Felker GM, Lee KL, Bull DA, Redfield MM, Stevenson LW, Goldsmith SR, LeWinter MM, Deswal A, Rouleau JL, Ofili EO, Anstrom KJ, Hernandez AF, McNulty SE, Velazquez EJ, Kfoury AG, Chen HH, Givertz MM, Semigran MJ, Bart BA, Mascette AM, Braunwald E, O'Connor CM; NHLBI Heart Failure Clinical Research Network. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011 Mar 3;364(9):797-805. doi: 10.1056/NEJMoa1005419.
- McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
- Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 May 3;79(17):e263-e421. doi: 10.1016/j.jacc.2021.12.012. Epub 2022 Apr 1.
- Tersalvi G, Dauw J, Gasperetti A, Winterton D, Cioffi GM, Scopigni F, Pedrazzini G, Mullens W. The value of urinary sodium assessment in acute heart failure. Eur Heart J Acute Cardiovasc Care. 2021 Apr 8;10(2):216-223. doi: 10.1093/ehjacc/zuaa006.
- Zheng Z, Jiang X, Chen J, He D, Xie X, Lu Y. Continuous versus intermittent use of furosemide in patients with heart failure and moderate chronic renal dysfunction. ESC Heart Fail. 2021 Jun;8(3):2070-2078. doi: 10.1002/ehf2.13286. Epub 2021 Mar 10.
- Suri SS,Pamboukian SV
- Tersalvi G,Dauw J,Gasperetti A,Winterton D,Cioffi GM,Scopigni F,Pedrazzini G,Mullens W
- Fatima S, Lambert W, Nouraie M, Pacella J. Bedside ultrasound to assess acute central venous pressure change during treatment of decompensated heart failure. Int J Cardiol Heart Vasc. 2022 Jun 2;41:101067. doi: 10.1016/j.ijcha.2022.101067. eCollection 2022 Aug.
- Tzadok B, Shapira S, Tal-Or E. Ultrasound of Jugular Veins for Assessment of Acute Dyspnea in Emergency Departments and for the Assessment of Acute Heart Failure. Isr Med Assoc J. 2018 May;20(5):308-310.
- Jassim HM, Naushad VA, Khatib MY, Chandra P, Abuhmaira MM, Koya SH, Ellitthy MSA. IJV collapsibility index vs IVC collapsibility index by point of care ultrasound for estimation of CVP: a comparative study with direct estimation of CVP. Open Access Emerg Med. 2019 Apr 3;11:65-75. doi: 10.2147/OAEM.S176175. eCollection 2019.
- Ng KT, Yap JLL. Continuous infusion vs. intermittent bolus injection of furosemide in acute decompensated heart failure: systematic review and meta-analysis of randomised controlled trials. Anaesthesia. 2018 Feb;73(2):238-247. doi: 10.1111/anae.14038. Epub 2017 Sep 22.
- Karedath J, Asif A, Tentu N, Zahra T, Batool S, Sathish M, Sandhu QI, Khan A. Continuous Infusion Versus Bolus Injection of Loop Diuretics for Patients With Congestive Heart Failure: A Meta-Analysis. Cureus. 2023 Feb 8;15(2):e34758. doi: 10.7759/cureus.34758. eCollection 2023 Feb.
- Alqahtani F, Koulouridis I, Susantitaphong P, Dahal K, Jaber BL. A meta-analysis of continuous vs intermittent infusion of loop diuretics in hospitalized patients. J Crit Care. 2014 Feb;29(1):10-7. doi: 10.1016/j.jcrc.2013.03.015. Epub 2013 May 14.
- Huang Y, Guo F, Chen D, Lin H, Huang J. Comparison of Different Furosemide Regimens in the Treatment of Acute Heart Failure: A Meta-Analysis. Comput Math Methods Med. 2022 Aug 18;2022:4627826. doi: 10.1155/2022/4627826. eCollection 2022.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ECevik2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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