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

University of Monastir

Status: Enrolling

Conditions: Acute Decompensated Heart Failure

Treatments: Drug: Placebo; Drug: Hypertonic Saline Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT05298098

HSS-ADHF

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 2 patient groups, including a placebo group

Hypertonic Saline Solution

Active Comparator group

Description:

50 ml of intravenous Hypertonic Saline Solution over 1 hour + 250mg of IV furosemide over 1 hour

Treatment:

Drug: Hypertonic Saline Solution

5% Dextrose solution

Placebo Comparator group

Description:

50ml of 5% Dextrose solution over 1 hour + 250mg of IV furosemide over 1 hour

Treatment:

Drug: Placebo