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Second Line-Acute Asthma
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9 Julio 2020 - 1:52pm
por Gladys
24 Marzo 2023 - 7:02am
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Intervention code
Injections, Intravenous
Injections, Intravenous
Administration, Intravenous
Administration, Intravenous
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Single Dose
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Record Verification Date
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Cambios a
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Revisión de 24 Marzo 2023 - 7:02am
Second Line-Acute Asthma
General information
Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.
Acronym of Public Title:
SeLAA
Scientific title:
Usefulness of second-line agents in children with acute asthma. Randomized study of clinical efficacy
Acronym of Scientific Title:
SeLAA
Secondary indentifying numbers:
Not applicable
Issuing authority of the secondary identifying numbers:
Not applicable
Primary sponsor:
Autonomous Service Antonio Patricio de Alcalá University Hospital (SAHUAPA)
Secondary sponsor:
Not applicable
Source(s) of monetary or material support:
Autonomous Service Antonio Patricio de Alcala University Hospital (SAHUAPA)
Authorization for beginning
Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.
Regulatory instance to authorize the initiation of the study:
Only approved by Ethics Committees
Principal investigator
Section to complete information about Email address, telephone number and postal address of the Principal Investigator.
First name:
Elias
Midle name:
Ibrahim
Last name:
Kassisse El Hage
Medical Specialty :
Pediatrician specialist II pediatric pulmonologist
Affiliation:
Herminda Martin Clinical Hospital
Postal address:
Francisco Ramirez avenue 10
City:
Chillan
País:
Chile
Zip Code:
3780000
Telephone:
+56-947893177
Email address:
ekassisse@gmail.com
Clinical sites to participate
Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.
Countries of recruitment:
Venezuela
Clinical sites:
Not applicable
Recruitment status
Section to complete information about the recruitment status and the date of first enrolment subject
Recruitment status:
Complete
Date of first enrollment:
01/04/2017
Health condition and Intervention
Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).
Health condition(s) or Problem(s) studied:
Acute asthma
Health condition(s) code:
Asthma
Bronchial Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Environmental Illness
Intervention(s):
Group I. Aminophylline (control): An initial loading dose calculated at 5 mg per Kg of weight intravenous followed by a continuous infusion calculated at 1mg per Kg per hour for the following 3 hours. Group II. Magnesium sulfate (MgSO4)(experimental): Single intravenous dose calculated at 50 mg per Kg of weight
Intervention code:
Aminophylline
Magnesium Sulfate
Infusions, Intravenous
Injections, Intravenous
Administration, Intravenous
Single Dose
Outcomes and Timepoint
Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
1. Asthma Severity: (Changes in the Asthma Severity Scale (ASS) score with respect to the baseline value.) Measurement time: baseline and, 180 minutes after the intervention . 2.Oxygen saturation (Percentage change from the baseline until final value). Measurement time: at baseline and, 180 minutes after intervention.
Key secondary outcomes:
1.Rate of hospitalized (Percentage of hospitalized patients). Measurement time: 180 minutes after intervention: 2. Need to transfer to the intensive care unit (Percentage of patients who required to be transferred to the intensive care units). Measurement time: 180 minutes after intervention. 3. Adverse effects (Percentage of patients with any reaction attributable to the use of medications). Measurement time: 180 minutes after intervention. 4.Need to use another type of medication (Percentage of patients required to use a third medication, that is, what percentage of those who initially used magnesium sulfate that they should have received aminophylline and what percentage of those who initially received aminophylline should have used magnesium sulfate). Measurement time: 180 minutes after intervention
Selection criterias
Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.
Gender:
Male/Female
Minimum age:
2 years
Maximum age:
12 years
Inclusion criteria:
1. Age greater than or equal to 2 years and less than or equal to 12 years 2. Previous diagnosis of asthma (more than 3 exacerbations that had improved with the use of salbutamol) 3.Consult for acute exacerbation of asthma
Exclusion criteria:
1.Children with chronic cardiac, immunological, pulmonary diseases other than asthma and hematology 2. Previous hospitalizations in the last 4 weeks for any reason 3.If they had received either of the medications under study
Type of population:
Children
Type of participant:
Patients
Study design
Section to complete information about the characteristics of the study design.
Type study:
Interventional
Purpose:
Treatment
Allocation:
Randomized controlled trial
Masking:
Single Blind
Control group:
Active
Study design:
Parallel
Phase:
N/A
Target sample size:
131
Contact for public queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status
First Name:
Elias
Middle Name:
Ibrahim
Last Name:
Kassisse El Hage
Specialty:
Pediatrician specialist II pediatric pulmonologist
Affiliation:
Herminda Martin Clinical Hospital
Postal Address:
Francisco Ramirez Avenue 10
City:
Chillan
País:
Chile
Zip Code:
3780000
Telephone:
+56 42 2586400
Email :
ekassisse@gmail.com
Contact for scientific queries
Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.
First Name:
Elias
Middle Name:
Ibrahim
Last Name:
Kassisse El Hage
Specialty:
Pediatrician specialist II pediatric pulmonologist
Affiliation:
Herminda Martin Clinical Hospital
Postal Address:
Francisco Ramirez Avenue 10
City:
Chillan
País:
Chile
Zip Code:
3780000
Telephone:
+56-422586400
Email :
ekassisse@gmail.com
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
Yes
Description of Data Sharing Plan:
primary and secondary results are shared as well as the tables that were prepared for the analysis and may be available from the time of registration number assignment
About study completion
Section to complete the data related to the study completion.
Final enrolment number:
131
Study completion date:
31/08/2018
Date of available results:
31/07/2020
Date of first publication:
28/08/2020
Registration and Update
Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).
Primary registry:
RPCEC
Unique ID number:
RPCEC00000324
Date of Registration in Primary Registry:
09/07/2020
Record Verification Date:
2020/10/21
Next update date:
2021/10/21
Link to the spanish version:
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