Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

Last updated: May 13, 2023
Sponsor: University of Monastir
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Hyponatremia

Heart Failure

Treatment

Placebo

Hypertonic Saline Solution

Clinical Study ID

NCT05298098
HSS-ADHF
  • Ages > 18
  • All Genders

Study Summary

Acute decompensated heart failure (HF) is one of the most common cardiologic issues in emergency departments.

Loop diuretics have long been recognized as the key for the treatment of Acute Decompensated Heart Failure (ADHF).However, chronic treatment with diuretics may limit their response and deteriorates the renal function. The hypertonic saline solution (HSS) has been proposed in recent years as an adjunctive therapy for intravenous loop diuretics to improve or restore their initial pharmacological efficacy.

In this study the investigators will evaluate the effectiveness of HSS as an adjunct to i.v. furosemide in patients admitted for AHF with renal dysfunction

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with 18 years of age or older
  • ADHF with congestive symptoms, laboratory(BNP) and echocardiographic criteria
  • NYHA ≥II(New York Heart Association functional classification)
  • Creatinine clearance≤60ml/mn (MDRD) or level of creatinine >150 µg/ml)
  • BNP levels on admission ≥400 pg/mL

Exclusion

Exclusion Criteria:

  • age < 18 years
  • NYHA class < II
  • Patients with acute coronary syndrome, pulmonary thromboembolism, cardiac tamponade,pericarditis, those on dialysis; patients with chronic liver disease, pleuropneumonia,cerebral vascular disease, cancer, uncompensated diabetes, patients requiringpacemaker and concomitant other important comorbidity
  • Signs of hemodynamic instability, respiratory distress, coma

Study Design

Total Participants: 600
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
July 01, 2018
Estimated Completion Date:
September 30, 2023

Study Description

In the era of the emergence of novel therapies for advanced Chronic Heart Failure , the use of HSS as a therapeutic adjunct to i.v. loop diuretics still needs to be explored on a larger scale, in particular in patients with renal dysfunction.

The objective of this study is: to evaluate the effectiveness of HSS as an adjunct to i.v. furose¬mide in patients admitted for AHF with renal dysfunction.

  • Patients receive intravenous infusion of HSS (50ml of 10% NaCl) + Furosemide ( 250mg of furosemide) administered over one hour twice a day.

  • Patients receive intravenous infusion of 5% Dextrose Solution (50ml of Dextrose 5%) + Furosemide (250mg of furosemide) administered over one hour twice a day.

Connect with a study center

  • Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

    Monastir, 5000
    Tunisia

    Active - Recruiting

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