Congestive Heart Failure, Renal Insufficiency
Conditions
Keywords
Congestive Heart Failure, Renal Insufficiency, Cardio-renal Syndrome
Brief 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).
Detailed 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).
Interventions
DRUGfurosemide and hypertonic saline solution
250-500 mg furosemide (30 min IV Q 12 hours) with 150 mL of 2.4% NaCl
DRUGfurosemide
80-160 mg furosemide (Given over 5 min IV twice a day)
Sponsors
Aspirus Wausau Hospital
Aspirus Heart and Vascular Institute-Research and Education
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Renal function (GFR) | 30 days |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization cost analysis | 30 days |
| 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 |
| BNP Levels | discharge, 30 days and 6 months |
| Readmission rate | 6 months |
| Weight loss | one week |
| Length of hospital stay | 30 days |
Countries
United States
Outcome results
None listed