Acute Decompensated Heart Failure
Conditions
Keywords
Hypertonic Saline Solution, Renal Dysfunction, Diuretic
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.
Interventions
Patients receive intravenous infusion of HSS (50ml of 10% NaCl) + Furosemide ( 250mg of furosemide) administered over one hour twice a day.
DRUGPlacebo
Patients receive intravenous infusion of 5% Dextrose Solution (50ml of Dextrose 5%) + Furosemide (250mg of furosemide) administered over one hour twice a day.
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay | 1 week | The period during which the patient is hospitalized |
| In-hospital mortality | 1 week | Death occuring during hospitalization |
| Renal Function Impairement | 1 week | Deterioration of renal function during hospital stay |
| Need for inotropic drugs | 1 week | Hemodynamic instability requiring the introduction of inotropic drugs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Renal Replacement Therapy | 1 week | Severe Impairment of renal function requiring urgent hemodialysis |
| Hospital Readmission | 30 days | Hospital readmission for acute heart failure during the 30 days following discharge |
| 30 day Mortality | 30 days | Death occurring during the 30 days following discharge |
Countries
Tunisia
Contacts
Primary ContactSemir Nouira, Professor
Backup ContactKhaoula Bel Haj Ali, MD
Outcome results
None listed