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Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure (HSS)

Primary Purpose

Acute Decompensated Heart Failure

Status

Recruiting

Phase

Not Applicable

Locations

Tunisia

Study Type

Interventional

Intervention

Hypertonic Saline Solution

Placebo

About this trial

This is an interventional treatment trial for Acute Decompensated Heart Failure focused on measuring Hypertonic Saline Solution, Renal Dysfunction, Diuretic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir TunisiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Hypertonic Saline Solution

5% Dextrose solution

Arm Description

50 ml of intravenous Hypertonic Saline Solution over 1 hour + 250mg of IV furosemide over 1 hour

50ml of 5% Dextrose solution over 1 hour + 250mg of IV furosemide over 1 hour

Outcomes

Primary Outcome Measures

Length of Hospital Stay

The period during which the patient is hospitalized

In-hospital mortality

Death occuring during hospitalization

Renal Function Impairement

Deterioration of renal function during hospital stay

Need for inotropic drugs

Hemodynamic instability requiring the introduction of inotropic drugs

Secondary Outcome Measures

30 day Mortality

Death occurring during the 30 days following discharge

Need for Renal Replacement Therapy

Severe Impairment of renal function requiring urgent hemodialysis

Hospital Readmission

Hospital readmission for acute heart failure during the 30 days following discharge

Full Information

NCT ID

NCT05298098

First Posted

January 17, 2022

Last Updated

May 13, 2023

Sponsor

University of Monastir

1. Study Identification

Unique Protocol Identification Number

NCT05298098

Brief Title

Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

Acronym

HSS

Official Title

Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Monastir

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Decompensated Heart Failure

Keywords

Hypertonic Saline Solution, Renal Dysfunction, Diuretic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

Masking

Participant

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypertonic Saline Solution

Arm Type

Active Comparator

Arm Description

50 ml of intravenous Hypertonic Saline Solution over 1 hour + 250mg of IV furosemide over 1 hour

Arm Title

5% Dextrose solution

Arm Type

Placebo Comparator

Arm Description

50ml of 5% Dextrose solution over 1 hour + 250mg of IV furosemide over 1 hour

Intervention Type

Drug

Intervention Name(s)

Hypertonic Saline Solution

Other Intervention Name(s)

Hypertonic Saline

Intervention Description

Patients receive intravenous infusion of HSS (50ml of 10% NaCl) + Furosemide ( 250mg of furosemide) administered over one hour twice a day.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Length of Hospital Stay

Description

The period during which the patient is hospitalized

Time Frame

1 week

Title

In-hospital mortality

Description

Death occuring during hospitalization

Time Frame

1 week

Title

Renal Function Impairement

Description

Deterioration of renal function during hospital stay

Time Frame

1 week

Title

Need for inotropic drugs

Description

Hemodynamic instability requiring the introduction of inotropic drugs

Time Frame

1 week

Secondary Outcome Measure Information:

Title

30 day Mortality

Description

Death occurring during the 30 days following discharge

Time Frame

30 days

Title

Need for Renal Replacement Therapy

Description

Severe Impairment of renal function requiring urgent hemodialysis

Time Frame

1 week

Title

Hospital Readmission

Description

Hospital readmission for acute heart failure during the 30 days following discharge

Time Frame

30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Semir Nouira, Professor

Phone

73106046

Ext

216

semir.nouira@rns.tn

First Name & Middle Initial & Last Name or Official Title & Degree

Khaoula Bel Haj Ali, MD

Phone

7310600

Ext

216

belhajalikhaoula@yahoo.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Semir Nouira, Professor

Organizational Affiliation

University of Monastir

Official's Role

Principal Investigator

Facility Information:

Facility Name

Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia

City

Monastir

ZIP/Postal Code

5000

Country

Tunisia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Semir Nouira, Professor

Phone

216 73106000

semir.nouira@rns.tn

12. IPD Sharing Statement

Learn more about this trial

Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

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