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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aspirus Heart and Vascular Institute-Research and Education
• Collaborator: Aspirus Wausau Hospital
• Treatments: Furosemide; Pharmaceutical Solutions

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.