Suspended

HSSHypertonic Saline Solution and Furosemide for Acute Heart Failure with Renal Dysfunction

Study Aim

This study aims to evaluate the effectiveness of Hypertonic Saline Solution and Furosemide treatment for Acute Heart Failure patients with Renal Dysfunction, focusing on in-hospital mortality, length of hospital stay, need for inotropic drugs, and renal function impairment.

What is being tested

Hypertonic Saline Solution

+ Placebo

Drug

Who is being recruted

Urogenital Diseases+4

+ Female Urogenital Diseases and Pregnancy Complications

+ Kidney Diseases

Over 18 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: July 2018

See protocol details

Summary

Principal SponsorUniversity of Monastir

Study ContactSemir Nouira, ProfessorMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2018

Actual date on which the first participant was enrolled.

This study focuses on the effects of Hypertonic Saline Solution (HSS) when used alongside a common medication, Furosemide, for treating Acute Decompensated Heart Failure (ADHF) in patients with kidney dysfunction. The goal is to explore if HSS can enhance the effectiveness of Furosemide, especially given the need for new therapies in advanced Chronic Heart Failure. The study is particularly important for patients with kidney dysfunction, as it aims to improve their care and address the challenges associated with their condition. Participants in this study receive an intravenous infusion of either HSS (50ml of 10% NaCl) or a 5% Dextrose Solution (50ml of Dextrose 5%), both administered with Furosemide (250mg of furosemide). These infusions are given over one hour, twice a day. The study measures several outcomes to evaluate the effectiveness of the treatment. These include in-hospital mortality, the length of hospital stay, the need for inotropic drugs (which are used to treat hemodynamic instability), and any impairment of kidney function during the hospital stay.

Official TitleImpact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

NCT05298098

Principal SponsorUniversity of Monastir

Study ContactSemir Nouira, ProfessorMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesUrologic DiseasesRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

5 inclusion criteria required to participate

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)

Show More Criteria

4 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

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

Group II

Placebo

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

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

Monastir, TunisiaOpen Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia in Google Maps

SuspendedOne Study Center