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HSS: Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

Sponsor
University of Monastir (Other)
Overall Status
Recruiting
CT.gov ID
NCT05298098
Collaborator
(none)
600
Enrollment
1
Location
2
Arms
62
Anticipated Duration (Months)
9.7
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Hypertonic Saline Solution
  • Drug: Placebo
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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 ADHFThe 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:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure
Actual Study Start Date :
Jul 1, 2018
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Hypertonic Saline Solution

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

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.
Other Names:
  • Hypertonic Saline

    		•
    Placebo Comparator: 5% Dextrose solution

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Length of Hospital Stay [1 week]

      The period during which the patient is hospitalized

    2. In-hospital mortality [1 week]

      Death occuring during hospitalization

    3. Renal Function Impairement [1 week]

      Deterioration of renal function during hospital stay

    4. Need for inotropic drugs [1 week]

      Hemodynamic instability requiring the introduction of inotropic drugs

    Secondary Outcome Measures

    1. 30 day Mortality [30 days]

      Death occurring during the 30 days following discharge

    2. Need for Renal Replacement Therapy [1 week]

      Severe Impairment of renal function requiring urgent hemodialysis

    3. Hospital Readmission [30 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia Monastir Tunisia 5000

    Sponsors and Collaborators

    • University of Monastir

    Investigators

    • Principal Investigator: Semir Nouira, Professor, University of Monastir

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, Professor, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT05298098
    Other Study ID Numbers:
    • HSS-ADHF
    First Posted:
    Mar 28, 2022
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pr. Semir Nouira, Professor, University of Monastir
    Hypertonic Saline Solution
    Renal Dysfunction
    Diuretic
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Apr 6, 2022