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

5 gennaio 2015 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

32

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Non più vecchio di 1 anno (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore 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
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rate of Admission
Lasso di tempo: 24 hours
Patients staying longer than 24h are considered to be admitted to ward.
24 hours
Time to Attain Discharge Criteria
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Discharge
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Mateus D Leme, MD, Sao Paulo University

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 luglio 2013

Completamento primario (Effettivo)

1 dicembre 2014

Completamento dello studio (Effettivo)

1 dicembre 2014

Date di iscrizione allo studio

Primo inviato

22 gennaio 2014

Primo inviato che soddisfa i criteri di controllo qualità

22 gennaio 2014

Primo Inserito (Stima)

24 gennaio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 gennaio 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 gennaio 2015

Ultimo verificato

1 gennaio 2015

Maggiori informazioni

Termini relativi a questo studio

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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