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Hypertonic Saline Solution in Heart Failure

Primary Purpose

Heart Failure, Renal Failure, Hyponatremia

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
NaCl 7,5% (Hypertonic Saline Solution)
NaCl 0,9%
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Renal failure, Hyponatremia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Heart Institute of São Paulo University Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Group of patients that will receive hypertonic saline solution (NaCl 7,5%)

Group of patients that will receive placebo

Outcomes

Primary Outcome Measures

Occurrence of renal disfunction

Secondary Outcome Measures

Improvement of hyponatremia
Improvement of congestive phenomena

Full Information

First Posted
November 8, 2007
Last Updated
June 6, 2014
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT00555685
Brief Title
Hypertonic Saline Solution in Heart Failure
Official Title
Hypertonic Saline Solution in Decompensated Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Renal Failure, Hyponatremia
Keywords
Heart Failure, Renal failure, Hyponatremia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Group of patients that will receive hypertonic saline solution (NaCl 7,5%)
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Group of patients that will receive placebo
Intervention Type
Drug
Intervention Name(s)
NaCl 7,5% (Hypertonic Saline Solution)
Intervention Description
Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days
Intervention Type
Drug
Intervention Name(s)
NaCl 0,9%
Intervention Description
Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days
Primary Outcome Measure Information:
Title
Occurrence of renal disfunction
Time Frame
During hospital admission
Secondary Outcome Measure Information:
Title
Improvement of hyponatremia
Time Frame
During hospital admission
Title
Improvement of congestive phenomena
Time Frame
During hospital admission

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edimar A Bocchi, Professor
Organizational Affiliation
Heart Failure (InCor) University of São Paulo Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute of São Paulo University Medical School
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
15880253
Citation
Rocha-e-Silva M, Poli de Figueiredo LF. Small volume hypertonic resuscitation of circulatory shock. Clinics (Sao Paulo). 2005 Apr;60(2):159-72. doi: 10.1590/s1807-59322005000200013. Epub 2005 Apr 26.
Results Reference
background
PubMed Identifier
12660669
Citation
Licata 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.
Results Reference
background
PubMed Identifier
17992382
Citation
Issa VS, Bacal F, Mangini S, Carneiro RM, Azevedo CH, Chizzola PR, Ferreira SM, Bocchi EA. Hypertonic saline solution for renal failure prevention in patients with decompensated heart failure. Arq Bras Cardiol. 2007 Oct;89(4):251-5. doi: 10.1590/s0066-782x2007001600007. English, Portuguese.
Results Reference
result
PubMed Identifier
22243938
Citation
Issa VS, Andrade L, Ayub-Ferreira SM, Bacal F, de Braganca AC, Guimaraes GV, Marcondes-Braga FG, Cruz FD, Chizzola PR, Conceicao-Souza GE, Velasco IT, Bocchi EA. Hypertonic saline solution for prevention of renal dysfunction in patients with decompensated heart failure. Int J Cardiol. 2013 Jul 15;167(1):34-40. doi: 10.1016/j.ijcard.2011.11.087. Epub 2012 Jan 12.
Results Reference
derived

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Hypertonic Saline Solution in Heart Failure

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