- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02045238
Inhaled Hypertonic Saline Use in the Emergency Department to Treat Acute Viral Bronchiolitis
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
Stato
Condizioni
Intervento / Trattamento
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
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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SP
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Sao Paulo, SP, Brasile, 05508-000
- University Hospital of Sao Paulo University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
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
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
|
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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.
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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
|
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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.
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24 hours
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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.
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24 hours
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Rate of Readmission After Discharge
Lasso di tempo: 5 days
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The mere attendance to the Emergency Department will not be isolately considered, as it may be due to a scheduled reevaluation.
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5 days
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Incidence of Adverse Effects
Lasso di tempo: 24 hours
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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
Sponsor
Investigatori
- Investigatore principale: Mateus D Leme, MD, Sao Paulo University
Pubblicazioni e link utili
Pubblicazioni generali
- Mandelberg A, Tal G, Witzling M, Someck E, Houri S, Balin A, Priel IE. Nebulized 3% hypertonic saline solution treatment in hospitalized infants with viral bronchiolitis. Chest. 2003 Feb;123(2):481-7. doi: 10.1378/chest.123.2.481.
- Kuzik BA, Al-Qadhi SA, Kent S, Flavin MP, Hopman W, Hotte S, Gander S. Nebulized hypertonic saline in the treatment of viral bronchiolitis in infants. J Pediatr. 2007 Sep;151(3):266-70, 270.e1. doi: 10.1016/j.jpeds.2007.04.010. Epub 2007 Jun 29.
- Anil AB, Anil M, Saglam AB, Cetin N, Bal A, Aksu N. High volume normal saline alone is as effective as nebulized salbutamol-normal saline, epinephrine-normal saline, and 3% saline in mild bronchiolitis. Pediatr Pulmonol. 2010 Jan;45(1):41-7. doi: 10.1002/ppul.21108.
- Zhang L, Mendoza-Sassi RA, Wainwright C, Klassen TP. Nebulised hypertonic saline solution for acute bronchiolitis in infants. Cochrane Database Syst Rev. 2013 Jul 31;(7):CD006458. doi: 10.1002/14651858.CD006458.pub3.
- Principi T, Komar L. A critical review of "a randomized trial of nebulized 3% hypertonic saline with epinephrine in the treatment of acute bronchiolitis in the emergency department.". J Popul Ther Clin Pharmacol. 2011;18(2):e273-4. Epub 2011 May 16. No abstract available.
- Jacobs JD, Foster M, Wan J, Pershad J. 7% Hypertonic saline in acute bronchiolitis: a randomized controlled trial. Pediatrics. 2014 Jan;133(1):e8-13. doi: 10.1542/peds.2013-1646. Epub 2013 Dec 16.
- Mandelberg A, Amirav I. Hypertonic saline or high volume normal saline for viral bronchiolitis: mechanisms and rationale. Pediatr Pulmonol. 2010 Jan;45(1):36-40. doi: 10.1002/ppul.21185. No abstract available.
- Kuzik BA, Flavin MP, Kent S, Zielinski D, Kwan CW, Adeleye A, Vegsund BC, Rossi C. Effect of inhaled hypertonic saline on hospital admission rate in children with viral bronchiolitis: a randomized trial. CJEM. 2010 Nov;12(6):477-84. doi: 10.1017/s1481803500012690.
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 1263/13 - University Hospital
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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