UnknownNot Applicable

Impact of Hypertonic Saline Solution on Acute Decompensated Heart Failure

Tunisia600 participantsStarted 2018-07-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Length of Hospital Stay

Timeframe: 1 week

In-hospital mortality

Timeframe: 1 week

Renal Function Impairement

Timeframe: 1 week

Need for inotropic drugs

Timeframe: 1 week

Trial details

NCT IDNCT05298098

SponsorUniversity of Monastir

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09

Contact for this trial

Semir Nouira, Professor

73106046 semir.nouira@rns.tn

View on ClinicalTrials.gov More Acute Decompensated Heart Failure trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.