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

This study has been completed.
Sponsor:
Collaborator:
Aspirus Wausau Hospital
Information provided by (Responsible Party):
Karen Olson, Aspirus Heart and Vascular Institute-Research and Education
ClinicalTrials.gov Identifier:
NCT01028170
First received: November 27, 2009
Last updated: February 8, 2012
Last verified: February 2012
  Purpose

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).


Condition Intervention Phase
Congestive Heart Failure
Renal Insufficiency
Drug: furosemide and hypertonic saline solution
Drug: furosemide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Aspirus Heart and Vascular Institute-Research and Education:

Primary Outcome Measures:
  • Renal function (GFR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Readmission rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Weight loss [ Time Frame: one week ] [ Designated as safety issue: No ]
  • BNP Levels [ Time Frame: discharge, 30 days and 6 months ] [ Designated as safety issue: No ]
  • Hospitalization cost analysis [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: November 2009
Study Completion Date: January 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Furosemide with Hypertonic Saline
Furosemide with 150 mL of 2.4% NaCl
Drug: furosemide and hypertonic saline solution
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)
Drug: furosemide
80-160 mg furosemide (Given over 5 min IV twice a day)

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01028170

Locations
United States, Wisconsin
Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
Aspirus Heart and Vascular Institute-Research and Education
Aspirus Wausau Hospital
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
  More Information

Additional Information:
Publications:
Responsible Party: Karen Olson, Research Manager, Aspirus Heart and Vascular Institute-Research and Education
ClinicalTrials.gov Identifier: NCT01028170     History of Changes
Other Study ID Numbers: REaCH-23.07.09
Study First Received: November 27, 2009
Last Updated: February 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Aspirus Heart and Vascular Institute-Research and Education:
Congestive Heart Failure
Renal Insufficiency
Cardio-renal Syndrome

Additional relevant MeSH terms:
Heart Failure
Renal Insufficiency
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Pharmaceutical Solutions
Furosemide
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 19, 2014