Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

Conditions
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Acute Decompensated Heart Failure

Intervention / Treatment
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* Drug: Hypertonic Saline Solution
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The present study is a single-center, randomized, double-blind, placebo-controlled trial performed in a tertiary hospital. It designed to evaluate the effects of the administration of hypertonic saline solution (NaCl 10%) + furosemide to patients with decompensated heart failure. Population: This study will include adult patients admitted in the emergency department for ADHF
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertonic Saline Solution, Renal Dysfunction, Diuretic