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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic Saline Solution | Active Comparator | 50 ml of intravenous Hypertonic Saline Solution over 1 hour + 250mg of IV furosemide over 1 hour |
|
| 5% Dextrose solution | Placebo Comparator | 50ml of 5% Dextrose solution over 1 hour + 250mg of IV furosemide over 1 hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic Saline Solution | Drug | Patients receive intravenous infusion of HSS (50ml of 10% NaCl) + Furosemide ( 250mg of furosemide) administered over one hour twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | The period during which the patient is hospitalized | 1 week |
| In-hospital mortality | Death occuring during hospitalization | 1 week |
| Renal Function Impairement | Deterioration of renal function during hospital stay | 1 week |
| Need for inotropic drugs | Hemodynamic instability requiring the introduction of inotropic drugs | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 30 day Mortality | Death occurring during the 30 days following discharge | 30 days |
| Need for Renal Replacement Therapy | Severe Impairment of renal function requiring urgent hemodialysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Semir Nouira, Professor | Contact | 73106046 | 216 | semir.nouira@rns.tn |
| Khaoula Bel Haj Ali, MD | Contact | 7310600 | 216 | belhajalikhaoula@yahoo.fr |
| Name | Affiliation | Role |
|---|---|---|
| Semir Nouira, Professor | University of Monastir | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency department of university hospital Fattouma Bourguiba of Monastir Monastir, Monastir Tunisia | Recruiting | Monastir | 5000 | Tunisia |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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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
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|
| Placebo | Drug | Patients receive intravenous infusion of 5% Dextrose Solution (50ml of Dextrose 5%) + Furosemide (250mg of furosemide) administered over one hour twice a day. |
|
| 1 week |
| Hospital Readmission | Hospital readmission for acute heart failure during the 30 days following discharge | 30 days |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |