Safety and Efficacy of Low Dose Hypertonic Saline Solution and High Dose Furosemide for Congestive Heart Failure

Study Overview
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Brief Summary
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The purpose of this study is to compare high dose furosemide in combination with low volume hypertonic saline solution (2.4%) with intermittent pulse dose furosemide in patients with pre treatment kidney function impairment. The hypothesis is that it will provide effective diuretic response and have a beneficial effect on preservation of renal function as compared to pulse furosemide in patients with pre-treatment renal impairment (GFR < 60 mL/min).

Detailed Description
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Currently, congestive heart failure (CHF) is the fastest growing heart-related diagnosis in North America, with the chance of a person experiencing it during their lifetime around 20%. In patients with CHF, acute decompensation requiring hospitalizations are common. Patients with renal insufficiency are more susceptible to worsening of renal function or overt renal failure in relation to an episode of decompensated heart failure. Thus, there is a great need for treatment to help patients with renal dysfunction that can simultaneously protect them from further renal deterioration. Preliminary evidence indicates that hypertonic saline solution (HSS) combined with high dose loop diuretics may improve the prognosis for patients with CHF. In two separate studies, this treatment was found to alleviate symptoms of CHF, and significantly reduce hospital length of stay, as well as reduce morbidity and mortality subsequent to hospital stay. So far, available studies have demonstrated that renal function is not compromised when using HSS and high dose furosemide as a treatment for CHF. Preliminary data from our institution suggests that low volume HSS combined with high dose furosemide may be beneficial for patients with renal insufficiency. Hypothesis: High dose furosemide in combination with low volume HSS provides effective diuretic response and has a beneficial effect on preservation of renal function while in hospital as compared to pulse furosemide in patients with pre-treatment renal impairment (GFR < 60 mL/min).

Official Title
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Assessing the Renal Consequences and Functional Efficacy of Low Dose Hypertonic Saline Solution and Furosemide for the Treatment of Congestive Heart Failure in a Randomized, Double Blind, Prospective Study

Conditions
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Congestive Heart Failure, Renal Insufficiency

Intervention / Treatment
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* Drug: furosemide and hypertonic saline solution
* Drug: furosemide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uncompensated CHF Framingham Criteria for HF 2 Major or 1 Major 2 minor Major criteria: Paroxysmal nocturnal dyspnea Neck vein distention Rales Radiographic cardiomegaly (increasing heart size on chest radiography) Acute pulmonary edema S3 gallop Increased central venous pressure (>16 cm H2O at right atrium) Hepatojugular reflux Weight loss > 4.5 kg in 5 days in response to treatment Minor criteria: Bilateral ankle edema Nocturnal cough Dyspnea on ordinary exertion Hepatomegaly Pleural effusion Decrease in vital capacity by one third from maximum recorded Tachycardia (heart rate>120 beats/min.) No Ejection Fraction Inclusion Criteria GFR £ 60 mL/min GFR (mL/min/1.73 m2) = 186 x (Scr)-1.154 x (Age)-0.203 x (0.742 if female) x (1.212 if African American) (conventional units). Informed consent Exclusion Criteria: Patients with Acute Coronary Syndrome Post -op patients within 90 days of previous surgery Patients currently on dialysis Hospice patients Patients < 18 years of age.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Furosemide with Hypertonic Saline<br>Furosemide with 150 mL of 2.4% NaCl | Drug: furosemide and hypertonic saline solution<br>* 250-500 mg furosemide (30 min IV Q 12 hours) with 150 mL of 2.4% NaCl<br>|
| Active Comparator: Pulse Furosemide<br>80-160 mg furosemide (Given over 5 min IV twice a day) | Drug: furosemide<br>* 80-160 mg furosemide (Given over 5 min IV twice a day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function (GFR) |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diuretic response (defined as achievement of weight within 2% of previously determined dry body weight or reaching a clinically compensated state including return of functional level to prior NYHA class as determined by the primary treating physician) |  | one week | 
| Length of hospital stay |  | 30 days | 
| Readmission rate |  | 6 months | 
| Weight loss |  | one week | 
| BNP Levels |  | discharge, 30 days and 6 months | 
| Hospitalization cost analysis |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congestive Heart Failure, Renal Insufficiency, Cardio-renal Syndrome