Hypertonic Saline Solution in Heart Failure

NCT00555685 | Completed Phase 2 DMC

• 1 other identifier: FAPESP 2007/04048-7
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Renal Failure; Hyponatremia

Keywords

Heart Failure; Renal failure; Hyponatremia

Outcome Measures

Primary Outcomes (1)

• Occurrence of renal disfunction

  During hospital admission

Secondary Outcomes (2)

• Improvement of hyponatremia

  During hospital admission

• Improvement of congestive phenomena

  During hospital admission

Study Arms (2)

A

ACTIVE COMPARATOR

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

Drug: NaCl 7,5% (Hypertonic Saline Solution)

B

PLACEBO COMPARATOR

Group of patients that will receive placebo

Drug: NaCl 0,9%

Interventions

NaCl 7,5% (Hypertonic Saline Solution) DRUG

Patients in the intervention arm will receive 100ml of NaCl 7,5, twice daily during 3 days

A

NaCl 0,9% DRUG

Patients in the placebo arm will receive 100ml of NaCl 0,9% twice daily during 3 days

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Heart Institute of São Paulo University Medical School

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (4)

• 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.

  PMID: 15880253 BACKGROUND

• 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.

  PMID: 12660669 BACKGROUND

• 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.

  PMID: 17992382 RESULT

• 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.

  PMID: 22243938 DERIVED

MeSH Terms

Conditions

Heart Failure; Renal Insufficiency; Hyponatremia

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Edimar A Bocchi, Professor

  Heart Failure (InCor) University of São Paulo Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Heart Failure Team Director

Study Record Dates

• First Submitted: November 8, 2007
• First Posted: November 9, 2007
• Study Start: February 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 10, 2014

Record last verified: 2014-06

Locations

BR (1)