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

February 8, 2012 updated by: Karen Olson, Aspirus Heart and Vascular Institute-Research and Education

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

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).

Study Overview

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Wisconsin
      • Wausau, Wisconsin, United States, 54401
        • Aspirus Wausau Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Furosemide with Hypertonic Saline
Furosemide with 150 mL of 2.4% NaCl
250-500 mg furosemide (30 min IV Q 12 hours) with 150 mL of 2.4% NaCl
Active Comparator: Pulse Furosemide
80-160 mg furosemide (Given over 5 min IV twice a day)
80-160 mg furosemide (Given over 5 min IV twice a day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Renal function (GFR)
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of hospital stay
Time Frame: 30 days
30 days
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)
Time Frame: one week
one week
Readmission rate
Time Frame: 6 months
6 months
Weight loss
Time Frame: one week
one week
BNP Levels
Time Frame: discharge, 30 days and 6 months
discharge, 30 days and 6 months
Hospitalization cost analysis
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Richard S Engelmeier, MD, Aspirus Heart and Vascular Institute-Research and Education
  • Study Director: German Larrain, MD, Aspirus Heart and Vascular Institute-Research and Education

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 27, 2009

First Submitted That Met QC Criteria

December 8, 2009

First Posted (Estimate)

December 9, 2009

Study Record Updates

Last Update Posted (Estimate)

February 9, 2012

Last Update Submitted That Met QC Criteria

February 8, 2012

Last Verified

February 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Insufficiency

Clinical Trials on furosemide and hypertonic saline solution

3
Subscribe