Heart Failure Clinical Trial
Safety and Efficacy of Low Dose Hypertonic Saline Solution and High Dose Furosemide for Congestive Heart Failure
Summary
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).
Full Description
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).
Eligibility Criteria
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.
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There is 1 Location for this study
Wausau Wisconsin, 54401, United States
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