Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

Acute Decompensated Heart Failure Clinical Trial

— HSS  

Official title:

Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05298098
• Other study ID #: HSS-ADHF
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: September 2023

Study information

• Verified date: May 2023
• Source: University of Monastir
• Contact: Semir Nouira, Professor
• Phone: 73106046
• Email: semir.nouira[@]rns.tn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Heart Failure

Intervention

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.
• Placebo
Patients receive intravenous infusion of 5% Dextrose Solution (50ml of Dextrose 5%) + Furosemide (250mg of furosemide) administered over one hour twice a day.

Locations

Country	Name	City	State
Tunisia	Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of Hospital Stay	The period during which the patient is hospitalized	1 week
Primary	In-hospital mortality	Death occuring during hospitalization	1 week
Primary	Renal Function Impairement	Deterioration of renal function during hospital stay	1 week
Primary	Need for inotropic drugs	Hemodynamic instability requiring the introduction of inotropic drugs	1 week
Secondary	30 day Mortality	Death occurring during the 30 days following discharge	30 days
Secondary	Need for Renal Replacement Therapy	Severe Impairment of renal function requiring urgent hemodialysis	1 week
Secondary	Hospital Readmission	Hospital readmission for acute heart failure during the 30 days following discharge	30 days