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

Completed · Phase 3

Conditions studied: Congestive Heart Failure, Renal Insufficiency

In brief

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).

Key facts

Study ID

NCT01028170

Run by

Aspirus Heart and Vascular Institute-Research and Education

People needed

50

Starts

2009-11-01

Expected to finish

2012-01-01

Last updated by the study team

2012-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Aspirus Wausau Hospital — Wausau, Wisconsin, United States

Full record on ClinicalTrials.gov

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