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OpenTrials
Completed

NCT Number: NCT00555685

Hypertonic Saline Solution in 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Hyponatremia Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Renal Failure Renal Insufficiency Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Heart Institute of São Paulo University Medical School

São Paulo, 05403-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NaCl 7,5% (Hypertonic Saline Solution)

Drug

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

NaCl 0,9%

Drug

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

Primary outcomes

  1. Occurrence of renal disfunction

    Time frame: During hospital admission

Secondary outcomes

  1. Improvement of hyponatremia

    Time frame: During hospital admission

  2. Improvement of congestive phenomena

    Time frame: During hospital admission

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Hypertonic Saline Solution in Decompensated Heart Failure

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 9, 2007
Registry last updated
Jun 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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