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

NCT01028170 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-02-09

No results posted yet for this study

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).

Conditions

  • Congestive Heart Failure
  • Renal Insufficiency

Interventions

DRUG

furosemide and hypertonic saline solution

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

DRUG

furosemide

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

Sponsors & Collaborators

  • Aspirus Wausau Hospital

    collaborator UNKNOWN

  • Aspirus Heart and Vascular Institute-Research and Education

    lead OTHER

Principal Investigators

  • Richard S Engelmeier, MD · Aspirus Heart and Vascular Institute-Research and Education

  • German Larrain, MD · Aspirus Heart and Vascular Institute-Research and Education

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-07-31
Completion
2012-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01028170 on ClinicalTrials.gov