Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure (HSS)

  • STATUS
    Recruiting
  • End date
    Sep 18, 2023
  • participants needed
    600
  • sponsor
    University of Monastir
Updated on 18 April 2022

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

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.

Details
Condition Acute Decompensated Heart Failure
Treatment Placebo, Hypertonic saline solution
Clinical Study IdentifierNCT05298098
SponsorUniversity of Monastir
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

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 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 requiring pacemaker and concomitant other important comorbidity
Signs of hemodynamic instability, respiratory distress, coma
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