Safety and Efficacy of Low Dose Hypertonic Saline Solution and High Dose Furosemide for Congestive Heart Failure
REaCH
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
1 other identifier
interventional
50
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 27, 2009
CompletedFirst Posted
Study publicly available on registry
December 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 9, 2012
February 1, 2012
1.7 years
November 27, 2009
February 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Renal function (GFR)
30 days
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
Furosemide with Hypertonic Saline
EXPERIMENTALFurosemide with 150 mL of 2.4% NaCl
Pulse Furosemide
ACTIVE COMPARATOR80-160 mg furosemide (Given over 5 min IV twice a day)
Interventions
250-500 mg furosemide (30 min IV Q 12 hours) with 150 mL of 2.4% NaCl
Eligibility Criteria
You may qualify if:
- Uncompensated CHF
- Framingham Criteria for HF
- Major or
- 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:
- +10 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aspirus Wausau Hospital
Wausau, Wisconsin, 54401, United States
Related Publications (5)
MacIntyre K, Capewell S, Stewart S, Chalmers JW, Boyd J, Finlayson A, Redpath A, Pell JP, McMurray JJ. Evidence of improving prognosis in heart failure: trends in case fatality in 66 547 patients hospitalized between 1986 and 1995. Circulation. 2000 Sep 5;102(10):1126-31. doi: 10.1161/01.cir.102.10.1126.
PMID: 10973841BACKGROUNDLapman PG, Golduber GN, Le Jemtel TH. Heart failure treatment and renal function. Am Heart J. 2004 Feb;147(2):193-4. doi: 10.1016/j.ahj.2003.10.003. No abstract available.
PMID: 14760310BACKGROUNDPaterna S, Parrinello G, Amato P, Dominguez L, Pinto A, Maniscalchi T, Cardinale A, Licata A, Amato V, Licata G, Di Pasquale P. Tolerability and efficacy of high-dose furosemide and small-volume hypertonic saline solution in refractory congestive heart failure. Adv Ther. 1999 Sep-Oct;16(5):219-28.
PMID: 10915397BACKGROUNDLicata G, Di Pasquale P, Parrinello G, Cardinale A, Scandurra A, Follone G, Argano C, Tuttolomondo A, Paterna S. Effects of high-dose furosemide and small-volume hypertonic saline solution infusion in comparison with a high dose of furosemide as bolus in refractory congestive heart failure: long-term effects. Am Heart J. 2003 Mar;145(3):459-66. doi: 10.1067/mhj.2003.166.
PMID: 12660669BACKGROUNDPaterna S, Di Pasquale P, Parrinello G, Fornaciari E, Di Gaudio F, Fasullo S, Giammanco M, Sarullo FM, Licata G. Changes in brain natriuretic peptide levels and bioelectrical impedance measurements after treatment with high-dose furosemide and hypertonic saline solution versus high-dose furosemide alone in refractory congestive heart failure: a double-blind study. J Am Coll Cardiol. 2005 Jun 21;45(12):1997-2003. doi: 10.1016/j.jacc.2005.01.059.
PMID: 15963399BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Manager
Study Record Dates
First Submitted
November 27, 2009
First Posted
December 9, 2009
Study Start
November 1, 2009
Primary Completion
July 1, 2011
Study Completion
January 1, 2012
Last Updated
February 9, 2012
Record last verified: 2012-02