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Epinephrine, Dexamethasone and Hypertonic Saline in Bronchiolitis

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2015 by Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Sponsor:
Information provided by (Responsible Party):
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
ClinicalTrials.gov Identifier:
NCT02585531
First received: October 13, 2015
Last updated: November 10, 2015
Last verified: October 2015
  Purpose

Bronchiolitis is one of the main reasons for consultation in primary care and emergency services, as well as the leading cause of hospitalization for lower respiratory tract infection in children under two years. There is still no consensus on the medical management of the disease, in clinical practice there is wide variability in the treatment with inhaled drugs and / or oral bronchodilators, steroids, antihistamines despite the viral etiology of the disease, which results in increased morbidity and a major economic benefit for all health services.

Several studies are in relation to the management of bronchiolitis, one of which was made during 2014 in the Naval Hospital of High Specialty which included 90 participants comparing 3 treatment. The treatments administered were: dexamethasone and epinephrine (Levogira) (ED), hypertonic saline 3% (SSH 3%)and saline 0.9% ( SS 0.9%), finding that the handling of ED and SSH 3% had lower rates of hospital admissions compared to the symptomatic management of SS 0.9%. Although the superiority of SSH3% and ED in relation to the use of SS 0.9% was demonstrated, it was not possible to establish difference statistically significant between them. Why it was considered necessary to continue the study focused on determining the difference in the effectiveness of ED and SSH 3%. Therefore, the purpose of this investigation is to determine whether there is a difference between the use of dexamethasone and epinephrine versus hypertonic saline (3%).


Condition Intervention Phase
Bronchiolitis
Drug: Hypertonic Saline 3%
Drug: Epinephrine and Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis in the Hospital General Naval de Alta Especialidad. A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Hospital General Naval de Alta Especialidad - Escuela Medico Naval:

Primary Outcome Measures:
  • Rate of hospital admissions [ Time Frame: 7 days after treatment ]
    Tracking each patient until 7 days after treatment to verify hospitalization rate.


Secondary Outcome Measures:
  • Respiration after treatment in the First Day. [ Time Frame: 20 minutes after administration of treatment. ]
    Breathing frequency after the application of nebulization in the First day of treatment (breath per minute).

  • Heart rate after treatment in the First Day. [ Time Frame: 20 minutes after administration of treatment. ]
    Heart rate after the application of nebulization in the First day of treatment (beat per minute).

  • Diastolic and Systolic blood pressure after treatment in the First Day. [ Time Frame: 20 minutes after administration of treatment. ]
    Diastolic and Systolic blood pressure after the application of nebulization in the First day of treatment (mmHg).

  • Oxygen Saturation After after treatment in the First Day. [ Time Frame: 20 minutes after administration of treatment. ]
    Oxygen Saturation after the application of nebulization in the First day of treatment (%).


Estimated Enrollment: 100
Study Start Date: November 2015
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HS3% group
Administration of nebulized hypertonic saline for 4 days. Hypertonic Saline 3% 3 ml.
Drug: Epinephrine and Dexamethasone

The treatment will be administered in the following order :

First day: One treatment of nebulized dexamethasone 4mg (1ml of dexamethasone 8mg/2ml) + 3ml NS, followed by two treatments of nebulized epinephrine (3 ml of epinephrine in a 1:1000 solution per treatment) with interval 20 minutes Second to fourth day: One treatment of nebulized dexamethasone 4 mg (1ml of dexamethasone 8mg/2ml) + 3ml Normal saline 0.9%, every 24 hours.

Other Name: ED
Active Comparator: ED group
Administration of nebulized epinephrine and dexamethasone for 4 days. Epinephrine 1:1000 solution. Dexamethasone solution 8mg/2ml.
Drug: Hypertonic Saline 3%

The treatment will be administered in the following order :

First day: 3 treatments of nebulized HS 3% 3ml of treatment with interval 20 minutes Second to fourth day: One treatment of nebulized HS 3% 3ml every 24 hours .

Other Name: HS3%

Detailed Description:

Respiratory tract infections are one of the leading causes of consultation in the Hospital General Naval de Alta Especialidad, in the emergency department and outpatient. Only in the last year (2014) shows that a total of 2690 pediatric consultations were provided in the emergency department, 1000 of them were for respiratory tract infections, constituting an approximate percentage of 37%. This figure increased over the previous year (2013) in which emergency visits corresponding 1130 290 cases consultations with boxes airways getting a percentage of 25% is given.

Due to the high incidence of lower respiratory tract infections among patients in the pediatric ward, specifically for infants under two patients; early diagnosis of acute bronchiolitis is essential to initiate proper management without falling into the overuse of drugs that have not shown adequate results.

In the last five years it has seen an increase in cases of bronchiolitis treated in both outpatient or emergency department of the Naval General Hospital. Given these data, a priority for a reason and consensus of treatment for patients with bronchiolitis.

Faced with these alarming epidemiological data both nationally and globally, it is difficult to understand that there is no consensus on the management of this entity. Although mortality is low, it represents a high cost for society and especially for health institutions, represented by a high rate of income, empirical treatments and other logistical issues.

This document intends to obtain evidence of better treatment in the population in order to establish an optimal management without spilling resources would reduce the rate of hospital admissions, first to the Naval General Hospital of High Specialty and then unify all Naval Health centers.

All this, on a solid foundation of knowledge, with the latest revisions in the interest of the subject, in order to provide the best care to every patient. Among the treatments given in this research the application of adrenaline is included, its usefulness is based on the action that causes on alpha receptors causing vasoconstriction, decreased blood flow and inflammation, responsible for the obstruction which is part of the pathophysiology of bronchiolitis. During the investigation it was decided to use it in its natural form (Levogira) because it is less expensive and the investigators can find it in an accessible at other institutions. Studies comparing its use in relation to the racemic epinephrine, show no difference. In addition to reporting a power 30 times higher in relation to the racemic epinephrine.

The study is feasible because the drugs used in this study are within the basic framework of hospital drugs, which do not involve any cost or use of additional staff for the hospital.

  Eligibility

Ages Eligible for Study:   2 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients under 2 years of age diagnosed with bronchiolitis
  • Be beneficiaries Marine
  • Outpatient
  • Severity of Bronchiolitis mild to moderate scale according to Difficulty rating scale Respiratory (RDAI) for bronchiolitis (RDAI score 2-8).

Exclusion Criteria:

  • Patients with a history of atopy
  • Patients with a history of asthma in infants.
  • Patients with comorbidity
  • RDAI> 9 at diagnosis.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02585531

Contacts
Contact: Dra. Mayra Rubí Arcos Cruz, Pediatrician (52) 55-28-300-519 may03_05@hotmail.com

Locations
Mexico
Hospital General Naval de Alta Especialidad
México, Distrito Federal, Distrito Federal, Mexico, 04480
Sponsors and Collaborators
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
Investigators
Principal Investigator: Dra. Mayra Rubi Arcos Cruz, Pediatrician Secretaria de Marina
  More Information

Publications:
Acosta A et all. Diagnóstico y manejo en niños con Bronquiolitis en fase aguda, México: Secretaria de Salud. Catálogo Maestro de Guías de práctica clínica IMSS-032-08. 2010.

Responsible Party: Hospital General Naval de Alta Especialidad - Escuela Medico Naval
ClinicalTrials.gov Identifier: NCT02585531     History of Changes
Other Study ID Numbers: HGNAE 06
Study First Received: October 13, 2015
Last Updated: November 10, 2015

Keywords provided by Hospital General Naval de Alta Especialidad - Escuela Medico Naval:
Bronchiolitis
Dexamethasone
Epinephrine
Hypertonic saline

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Epinephrine
Racepinephrine
Epinephryl borate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on March 29, 2017