Skip to main content
OpenTrials
Completed

NCT Number: NCT01028170

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aspirus Wausau Hospital

Wausau, Wisconsin, 54401, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

furosemide and hypertonic saline solution

Drug

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

Furosemide

Drug

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

Primary outcomes

  1. Renal function (GFR)

    Time frame: 30 days

Secondary outcomes

  1. 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

  2. Length of hospital stay

    Time frame: 30 days

  3. Readmission rate

    Time frame: 6 months

  4. Weight loss

    Time frame: one week

  5. BNP Levels

    Time frame: discharge, 30 days and 6 months

  6. Hospitalization cost analysis

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Aspirus Heart and Vascular Institute-Research and Education

Other

Collaborators

  • Aspirus Wausau Hospital

Registry information

Official study 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

Acronym: REaCH

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Dec 9, 2009
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.