Hypertonic Saline Solution in Heart Failure

Heart Failure Clinical Trial

Official title:

Hypertonic Saline Solution in Decompensated Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00555685
• Other study ID #: FAPESP 2007/04048-7
• Status: Completed
• Phase: Phase 2
• First received: November 8, 2007
• Last updated: June 6, 2014
• Start date: February 2008
• Est. completion date: December 2010

Study information

• Verified date: June 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Hyponatremia
• Renal Failure
• Renal Insufficiency

Intervention

Drug:
• NaCl 7,5% (Hypertonic Saline Solution)
Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days
• NaCl 0,9%
Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days

Locations

Country	Name	City	State
Brazil	Heart Institute of São Paulo University Medical School	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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. English, Portuguese. — View 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. — View 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. Epub 2005 Apr 26. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of renal disfunction		During hospital admission	Yes
Secondary	Improvement of hyponatremia		During hospital admission	No
Secondary	Improvement of congestive phenomena		During hospital admission	No