Clinical trial NCT00555685: Hypertonic Saline Solution in Heart Failure
Official title: Hypertonic Saline Solution in Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Heart Failure
Renal Failure
Hyponatremia
Keywords: Heart Failure
Renal failure
Hyponatremia
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2007-11-09
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Occurrence of renal disfunction
timeFrame: During hospital admission
Secondary outcomes:
measure: Improvement of hyponatremia
timeFrame: During hospital admission
measure: Improvement of congestive phenomena
timeFrame: During hospital admission
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute of São Paulo University Medical School
state: SP
Study officials:
affiliation: Heart Failure (InCor) University of São Paulo Medical School
name: Edimar A Bocchi, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.