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

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

Study Overview

• Status: Recruiting
• Conditions: Acute Decompensated Heart Failure
• Intervention / Treatment: Drug: Hypertonic Saline Solution; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Semir Nouira, Professor; Phone Number: 216 73106046; Email: semir.nouira@rns.tn
• Study Contact Backup: Name: Khaoula Bel Haj Ali, MD; Phone Number: 216 7310600; Email: belhajalikhaoula@yahoo.fr

Study Locations

• Tunisia
  • Monastir, Tunisia, 5000
    • Recruiting
    • Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
    • Contact: Semir Nouira, Professor; Phone Number: 216 73106000; Email: semir.nouira@rns.tn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Hypertonic Saline Solution; 50 ml of intravenous Hypertonic Saline Solution over 1 hour + 250mg of IV furosemide over 1 hour	Drug: Hypertonic Saline Solution; Patients receive intravenous infusion of HSS (50ml of 10% NaCl) + Furosemide ( 250mg of furosemide) administered over one hour twice a day.; Other Names: Hypertonic Saline
Placebo Comparator: 5% Dextrose solution; 50ml of 5% Dextrose solution over 1 hour + 250mg of IV furosemide over 1 hour	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	The period during which the patient is hospitalized	1 week
In-hospital mortality	Death occuring during hospitalization	1 week
Renal Function Impairement	Deterioration of renal function during hospital stay	1 week
Need for inotropic drugs	Hemodynamic instability requiring the introduction of inotropic drugs	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day Mortality	Death occurring during the 30 days following discharge	30 days
Need for Renal Replacement Therapy	Severe Impairment of renal function requiring urgent hemodialysis	1 week
Hospital Readmission	Hospital readmission for acute heart failure during the 30 days following discharge	30 days

Collaborators and Investigators

• Sponsor: University of Monastir
• Investigators: Principal Investigator: Semir Nouira, Professor, University of Monastir

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 13, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Diuretic; Renal Dysfunction; Hypertonic Saline Solution
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: HSS-ADHF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No