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

Phase 3

Completed

• Conditions: Congestive Heart Failure; Renal Insufficiency
• Interventions: Drug: furosemide and hypertonic saline solution; Drug: furosemide

• Registration Number: NCT01028170
• Lead Sponsor: Aspirus Heart and Vascular Institute-Research and Education

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).

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-27
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Primary Completion: 2011-07
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Furosemide with Hypertonic Saline	furosemide and hypertonic saline solution	Furosemide with 150 mL of 2.4% NaCl
Pulse Furosemide	furosemide	80-160 mg furosemide (Given over 5 min IV twice a day)

Primary Outcome Measures

Name	Time	Method
Renal function (GFR)	30 days

Secondary Outcome Measures

Name	Time	Method
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
Length of hospital stay	30 days
Readmission rate	6 months
Weight loss	one week
BNP Levels	discharge, 30 days and 6 months
Hospitalization cost analysis	30 days

Trial Locations

Locations (1)

Aspirus Wausau Hospital; 🇺🇸 Wausau, Wisconsin, United States