Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

NCT ID: NCT05298098

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2023-09-30

Brief 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

Detailed 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.

Conditions

Acute Decompensated Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Hypertonic Saline Solution

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

Group Type: ACTIVE_COMPARATOR

Hypertonic Saline Solution

Intervention Type: DRUG

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

5% Dextrose solution

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Hypertonic Saline Solution

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Hypertonic Saline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Pr. Semir Nouira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Semir Nouira, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

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

Monastir, , Tunisia

Site Status: RECRUITING

Countries

Tunisia

Central Contacts

Semir Nouira, Professor

Role: CONTACT

semir.nouira@rns.tn

73106046 ext. 216

Khaoula Bel Haj Ali, MD

Role: CONTACT

belhajalikhaoula@yahoo.fr

7310600 ext. 216

Facility Contacts

Semir Nouira, Professor

Role: primary

semir.nouira@rns.tn

216 73106000

Other Identifiers

HSS-ADHF

Identifier Type: -

Identifier Source: org_study_id