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Inhaled Hypertonic Saline Use in the Emergency Department to Treat Acute Viral Bronchiolitis

5 de janeiro de 2015 atualizado por: Mateus Deckers Leme, University of Sao Paulo

Study of the Effect of Inhaled 3% Hypertonic Saline Compared With Normal Saline (0,9%) for the Treatment of Acute Viral Bronchiolitis in a Short Stay Ward

Acute viral bronchiolitis is an extremely common childhood disease, responsible for approximately 17% of childhood admissions to hospital per year, with an annually cost that reaches U$ 500 million.

Despite being a well known disease among pediatricians, there are few, if any, effective treatment options apart from oxygen supplementation and adequate hydration.

The purpose of this study is to determine wether nebulized hypertonic saline (3%) is more effective than normal saline (0,9%) when used in repeated doses during the first 24 hours of in-hospital treatment.

Visão geral do estudo

Descrição detalhada

Acute viral bronchiolitis is a lower airway infection, caused manly by Respiratory Syncytial Virus. Near 1% of children up to 2 years of age get it with sufficient severity to warrant hospital admission, with an annual cost of about U$ 500 million in the US, superior, for instance, than cystic fibrosis annual cost.

Despite the physiopathology and clinical course being well known among pediatricians, few therapeutical options other than adequate hydration and oxygen supplementation have proven to be effective Corticosteroids are not effective and bronchodilators are controversial, and treatment is still mostly empiric and lacking evidence.

In the last few years, there has been a growing interest in the use of nebulized hypertonic saline (HS) as a promising approach. The rational is that HS would help reducing edema and mucus viscosity, enhancing its rheologic properties. Recent studies suggest that HS could reduce up to 1 day (25%) of time until discharge in admitted patients. In the Emergency Department, HS was not superior to other forms of treatment, but these studies lack power and similarities to draw further conclusions. Also, time of treatment and ideal interval between doses are not known as yet.

To our knowledge, few if any studies have assessed patients with an intermediary (up to 24h) time of stay, namely a short stay ward attached to an emergency department. Thus, we have endeavoured to determine if repeated doses of nebulized HS are superior to nebulized normal saline (NS) during the first 24 hour of treatment, when considered: rate of admission, time until discharge, time until attain discharge criteria, and rate of readmission after discharge.

Furthermore, most studies use HS associated to a bronchodilator, because of a theoretical possibility that HS alone could induce bronchoconstriction and worsen respiratory symptoms. However, recent studies have shown that HS use without bronchodilators have not caused any worsening of symptoms in bronchiolitis patients. Therefore, we propose to study the effect of HS alone, without the adding of bronchodilators, which would minimize bias in the treatment group.

Tipo de estudo

Intervencional

Inscrição (Real)

32

Estágio

  • Não aplicável

Contactos e Locais

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Locais de estudo

    • SP
      • Sao Paulo, SP, Brasil, 05508-000
        • University Hospital of Sao Paulo University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

Não mais velho que 1 ano (Filho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Age < 12 months
  • Clinical diagnosis of bronchiolitis (viral respiratory disease and wheezing)
  • First episode of wheezing in life
  • Moderate respiratory distress, defined as 2 of the following: Sat <93%, respiratory rate >60 and/or RDAI score >4

Exclusion Criteria:

  • Previous episodes of wheezing in history
  • Use of bronchodilators, corticosteroids or antibiotics in the 24 hours prior to admission or at any time during treatment.
  • Other clinical conditions such as: prematurity, bronchopulmonary dysplasia, cystic fibrosis, cardiac disease or immunodeficiencies.
  • detection of alveolar infiltrates suggestive of pneumonia in radiologic examination
  • respiratory impairment requiring mechanical ventilation on arrival to hospital.

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Normal Saline
Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Immunofluorescence analysis of nasal aspirate
Experimental: Hypertonic Saline
Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.
Immunofluorescence analysis of nasal aspirate
Sodium Chloride 3% solution, previously prepared in 5 mL syringes.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Rate of Admission
Prazo: 24 hours
Patients staying longer than 24h are considered to be admitted to ward.
24 hours
Time to Attain Discharge Criteria
Prazo: 24 hours
Discharge criteria are: Room air saturation >94% AND respiratory rate < 60 AND Respiratory Distress Assessment Instrument (RDAI) score inferior than 4, maintained over a 4 hour period.
24 hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Time to Discharge
Prazo: 24 hours
Actual time to discharge was considered of secondary importance as it can be influenced by individual considerations like patient age or time of the day.
24 hours
Rate of Readmission After Discharge
Prazo: 5 days
The mere attendance to the Emergency Department will not be isolately considered, as it may be due to a scheduled reevaluation.
5 days
Incidence of Adverse Effects
Prazo: 24 hours
Any adverse effects directly attributable to treatment shall be noted. Mere lack of improve or worsening of symptoms attributable to the disease clinical course will not be considered as adverse effects.
24 hours

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Mateus D Leme, MD, Sao Paulo University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2013

Conclusão Primária (Real)

1 de dezembro de 2014

Conclusão do estudo (Real)

1 de dezembro de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

22 de janeiro de 2014

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de janeiro de 2014

Primeira postagem (Estimativa)

24 de janeiro de 2014

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

12 de janeiro de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de janeiro de 2015

Última verificação

1 de janeiro de 2015

Mais Informações

Termos relacionados a este estudo

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