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

NCT07464249 | Completed

• 1 other identifier: ECevik2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Decompensated Heart Failure (ADHF)

Keywords

acute decompensated heart failure; diuretics; furosemide; Jugular venous collapsibilty index; natriuresis; spot urinary sodium

Outcome Measures

Primary Outcomes (1)

• Diuresis

  Total cumulative urine output

  2nd and 4th hours after administration of Furosemide

Secondary Outcomes (1)

• Juguler Venous Collapsibility Index Change

  after administration of furosemide, 2nd and 4th hour

Other Outcomes (1)

• Spot Urinary Sodium

  2 hours and 4 hours after Furosemide administration

Study Arms (2)

Bolus Group

EXPERIMENTAL

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.

Drug: Furosemide Bolus

İnfusion Group

EXPERIMENTAL

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.

Drug: Furosemide Continuous İnfusion

Interventions

Furosemide Bolus DRUG

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

Also known as: Bolus diuretics

Bolus Group

Furosemide Continuous İnfusion DRUG

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

Also known as: continuous infusion diuretics

İnfusion Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey: lead

Study Sites (1)

Sultan 2. Abdulhamid Han Research and Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (14)

• 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.

  PMID: 33620424 BACKGROUND

• 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.

  PMID: 33689236 BACKGROUND

• Suri SS,Pamboukian SV

  BACKGROUND

• Tersalvi G,Dauw J,Gasperetti A,Winterton D,Cioffi GM,Scopigni F,Pedrazzini G,Mullens W

  BACKGROUND

• 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.

  PMID: 35676916 BACKGROUND

• 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.

  PMID: 29761678 BACKGROUND

• 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.

  PMID: 31040727 BACKGROUND

• 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.

  PMID: 21366472 BACKGROUND

• 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.

  PMID: 28940440 BACKGROUND

• 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.

  PMID: 36909062 BACKGROUND

• 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.

  PMID: 23683555 BACKGROUND

• 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.

  PMID: 36035285 BACKGROUND

• 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.

  PMID: 34447992 BACKGROUND

• 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.

  PMID: 35379503 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double Blind (Participant, Care Provider, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 11, 2026
• Study Start: April 3, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)