NCT01028170

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Aspirus Heart and Vascular Institute-Research and Education · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Congestive Heart Failure
• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	furosemide and hypertonic saline solution	250-500 mg furosemide (30 min IV Q 12 hours) with 150 mL of 2.4% NaCl
DRUG	furosemide	80-160 mg furosemide (Given over 5 min IV twice a day)

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-07-01
• Completion: 2012-01-01
• First posted: 2009-12-09
• Last updated: 2012-02-09

Locations

1 site across 1 country: United States