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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
Sponsored by
University of Monastir
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
January 17, 2022
Last Updated
May 13, 2023
Sponsor
University of Monastir
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
No
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
Email
semir.nouira@rns.tn
First Name & Middle Initial & Last Name or Official Title & Degree
Khaoula Bel Haj Ali, MD
Phone
7310600
Ext
216
Email
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
Email
semir.nouira@rns.tn

12. IPD Sharing Statement

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Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

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