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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-01-31

Brief Summary

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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).

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Detailed Description

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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

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Congestive Heart Failure Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Furosemide with Hypertonic Saline

Furosemide with 150 mL of 2.4% NaCl

Group Type EXPERIMENTAL

furosemide and hypertonic saline solution

Intervention Type DRUG

250-500 mg furosemide (30 min IV Q 12 hours) with 150 mL of 2.4% NaCl

Pulse Furosemide

80-160 mg furosemide (Given over 5 min IV twice a day)

Group Type ACTIVE_COMPARATOR

furosemide

Intervention Type DRUG

80-160 mg furosemide (Given over 5 min IV twice a day)

Interventions

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furosemide and hypertonic saline solution

250-500 mg furosemide (30 min IV Q 12 hours) with 150 mL of 2.4% NaCl

Intervention Type DRUG

furosemide

80-160 mg furosemide (Given over 5 min IV twice a day)

Intervention Type DRUG

Eligibility Criteria

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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.)
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No