Hypertonic Saline Solution in Heart Failure

June 6, 2014 updated by: Edimar Alcides Bocchi, University of Sao Paulo

Hypertonic Saline Solution in Decompensated Heart Failure

Patients with decompensated heart failure have high rates of mortality and morbidity despite recent improvements in diagnosis and treatment. Some aspects of their presentation such as renal failure, hyponatremia and congestive phenomena have received special attention, as they are associated with worse prognosis. The infusion of hypertonic saline solution has been tested in different conditions of cardiovascular collapse. Current evidence indicates that the infusion of hypertonic solution in heart failure patients can provide clinical and haemodynamic improvement. The investigators are testing the hypothesis that the infusion of hypertonic solution in association with diuretics may prevent the occurrence of renal dysfunction in patients with decompensated heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

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

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-000
        • Heart Institute of São Paulo University Medical School

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:

  • Age over 18 years old
  • Heart failure according to Framingham criteria
  • Episode of acute decompensation,with need of in-hospital treatment
  • Presence of congestive phenomena

Exclusion Criteria:

  • Patient denial
  • Left-ventricle ejection fraction over 0,4, as measure by transthoracic echocardiography
  • Rheumatic disease
  • Restrictive cardiomyopathy
  • Alcohol abuse
  • Chronic obstructive pulmonary disease
  • Cancer
  • Pulmonary embolism during the last 6 months
  • Surgical procedures or acute illness during the last 30 days
  • Chronic or acute infection
  • Any other circumstance that may hamper patient prognosis for the next 6 months
  • Serum creatine over 3.0mg/dL
  • Serum potassium over 5.5 mEqs/L
  • Any specific condition associated to the acute episode of decompensation, such as new onset cardiac arrhythmias, heart ischemia, infection, etc.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
Group of patients that will receive hypertonic saline solution (NaCl 7,5%)
Drug: NaCl 7,5% (Hypertonic Saline Solution)
Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days
Placebo Comparator: B
Group of patients that will receive placebo
Drug: NaCl 0,9%
Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of renal disfunction
Time Frame: During hospital admission
During hospital admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of hyponatremia
Time Frame: During hospital admission
During hospital admission
Improvement of congestive phenomena
Time Frame: During hospital admission
During hospital admission

Collaborators and Investigators

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

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Edimar A Bocchi, Professor, Heart Failure (InCor) University of São Paulo Medical School

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

February 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

November 8, 2007

First Submitted That Met QC Criteria

November 8, 2007

First Posted (Estimate)

November 9, 2007

Study Record Updates

Last Update Posted (Estimate)

June 10, 2014

Last Update Submitted That Met QC Criteria

June 6, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAPESP 2007/04048-7

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.

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