Clinical trial NCT05298098: Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure
Official title: Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Decompensated Heart Failure
Keywords: Hypertonic Saline Solution
Renal Dysfunction
Diuretic
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of Hospital Stay
timeFrame: 1 week
measure: In-hospital mortality
timeFrame: 1 week
measure: Renal Function Impairement
timeFrame: 1 week
measure: Need for inotropic drugs
timeFrame: 1 week
Secondary outcomes:
measure: 30 day Mortality
timeFrame: 30 days
measure: Need for Renal Replacement Therapy
timeFrame: 1 week
measure: Hospital Readmission
timeFrame: 30 days
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia
Study officials:
affiliation: University of Monastir
name: Semir Nouira, Professor
role: PRINCIPAL_INVESTIGATOR
References: