An interventional study of Hypertonic Saline Solution and Placebo in Acute Decompensated Heart Failure, sponsored by University of Monastir. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-16.
Sponsored by University of Monastir · Not applicable, Interventional, and Treatment
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
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 600 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Monastir is the lead sponsor of 112 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 ml of intravenous Hypertonic Saline Solution over 1 hour + 250mg of IV furosemide over 1 hour
Drug: Hypertonic Saline Solution
50ml of 5% Dextrose solution over 1 hour + 250mg of IV furosemide over 1 hour
Drug: Placebo
Patients receive intravenous infusion of HSS (50ml of 10% NaCl) + Furosemide ( 250mg of furosemide) administered over one hour twice a day.
Also known as: Hypertonic Saline
Patients receive intravenous infusion of 5% Dextrose Solution (50ml of Dextrose 5%) + Furosemide (250mg of furosemide) administered over one hour twice a day.
Length of Hospital Stay
The period during which the patient is hospitalized
Time frame: 1 week
In-hospital mortality
Death occuring during hospitalization
Time frame: 1 week
Renal Function Impairement
Deterioration of renal function during hospital stay
Time frame: 1 week
Need for inotropic drugs
Hemodynamic instability requiring the introduction of inotropic drugs
Time frame: 1 week
30 day Mortality
Death occurring during the 30 days following discharge
Time frame: 30 days
Need for Renal Replacement Therapy
Severe Impairment of renal function requiring urgent hemodialysis
Time frame: 1 week
Hospital Readmission
Hospital readmission for acute heart failure during the 30 days following discharge
Time frame: 30 days
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University of Monastir