Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure
- Conditions
- Acute Decompensated Heart Failure
- Interventions
- Drug: Hypertonic Saline SolutionDrug: Placebo
- Registration Number
- NCT05298098
- Lead Sponsor
- University of Monastir
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 600
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hypertonic Saline Solution Hypertonic Saline Solution 50 ml of intravenous Hypertonic Saline Solution over 1 hour + 250mg of IV furosemide over 1 hour 5% Dextrose solution Placebo 50ml of 5% Dextrose solution over 1 hour + 250mg of IV furosemide over 1 hour
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 30 day Mortality 30 days Death occurring during the 30 days following discharge
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
Trial Locations
- Locations (1)
Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
🇹🇳Monastir, Tunisia