Epinephrine, Dexamethasone and Hypertonic Saline in Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Unknown status
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Hypertonic Saline 3%
Epinephrine and Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, Dexamethasone, Epinephrine, Hypertonic saline
Eligibility 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.
Sites / Locations
- Hospital General Naval de Alta Especialidad
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
HS3% group
ED group
Arm Description
Administration of nebulized hypertonic saline for 4 days. Hypertonic Saline 3% 3 ml.
Administration of nebulized epinephrine and dexamethasone for 4 days. Epinephrine 1:1000 solution. Dexamethasone solution 8mg/2ml.
Outcomes
Primary Outcome Measures
Rate of hospital admissions
Tracking each patient until 7 days after treatment to verify hospitalization rate.
Secondary Outcome Measures
Respiration after treatment in the First Day.
Breathing frequency after the application of nebulization in the First day of treatment (breath per minute).
Heart rate after treatment in the First Day.
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.
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.
Oxygen Saturation after the application of nebulization in the First day of treatment (%).
Full Information
NCT ID
NCT02585531
First Posted
October 13, 2015
Last Updated
November 10, 2015
Sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
1. Study Identification
Unique Protocol Identification Number
NCT02585531
Brief Title
Epinephrine, Dexamethasone and Hypertonic Saline in Bronchiolitis
Official Title
Epinephrine, Dexamethasone, and Hypertonic Saline in Children With Bronchiolitis in the Hospital General Naval de Alta Especialidad. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital General Naval de Alta Especialidad - Escuela Medico Naval
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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%).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, Dexamethasone, Epinephrine, Hypertonic saline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HS3% group
Arm Type
Experimental
Arm Description
Administration of nebulized hypertonic saline for 4 days. Hypertonic Saline 3% 3 ml.
Arm Title
ED group
Arm Type
Active Comparator
Arm Description
Administration of nebulized epinephrine and dexamethasone for 4 days. Epinephrine 1:1000 solution. Dexamethasone solution 8mg/2ml.
Intervention Type
Drug
Intervention Name(s)
Hypertonic Saline 3%
Other Intervention Name(s)
HS3%
Intervention Description
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 .
Intervention Type
Drug
Intervention Name(s)
Epinephrine and Dexamethasone
Other Intervention Name(s)
ED
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of hospital admissions
Description
Tracking each patient until 7 days after treatment to verify hospitalization rate.
Time Frame
7 days after treatment
Secondary Outcome Measure Information:
Title
Respiration after treatment in the First Day.
Description
Breathing frequency after the application of nebulization in the First day of treatment (breath per minute).
Time Frame
20 minutes after administration of treatment.
Title
Heart rate after treatment in the First Day.
Description
Heart rate after the application of nebulization in the First day of treatment (beat per minute).
Time Frame
20 minutes after administration of treatment.
Title
Diastolic and Systolic blood pressure after treatment in the First Day.
Description
Diastolic and Systolic blood pressure after the application of nebulization in the First day of treatment (mmHg).
Time Frame
20 minutes after administration of treatment.
Title
Oxygen Saturation After after treatment in the First Day.
Description
Oxygen Saturation after the application of nebulization in the First day of treatment (%).
Time Frame
20 minutes after administration of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dra. Mayra RubΓ Arcos Cruz, Pediatrician
Phone
(52) 55-28-300-519
Email
may03_05@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dra. Mayra Rubi Arcos Cruz, Pediatrician
Organizational Affiliation
Secretaria de Marina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Naval de Alta Especialidad
City
MΓ©xico, Distrito Federal
State/Province
Distrito Federal
ZIP/Postal Code
04480
Country
Mexico
12. IPD Sharing Statement
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Epinephrine, Dexamethasone and Hypertonic Saline in Bronchiolitis
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