Effect of adjunctive nebulized magnesium sulfate on symptoms and lung volumes, in patients presenting with acute exacerbation of chronic obstructive pulmonary disease
1. Objectives: Acute exacerbation is a fact during natural course of chronic obstructive pulmonary disease (COPD) and the optimal treatments are still subject of ongoing researches. In this study we want to investigate the short term, in-hospital outcome of nebulized Magnesium sulfate in the terms of subjective and objective improvement in acute COPD exacerbation.
2. Design: Patients presented with acute COPD exacerbation will be randomly assigned (using random number table) to group-A and group-B. In addition to standard treatment, Group-A patients will receive Magnesium Sulfate by nebulizer mask and group-B will receive placebo.
3. Setting and conduct: Both group of patient will receive drug or placebo in similar container just before diagnostic tests. In addition to patients, researcher (who gathers the data) will not be aware of drug/placebo group.
4. Participants including major eligibility criteria: patients with known history of COPD presenting to emergency department with acute disease exacerbation will be included. Those with other associated medical disorders and unstable/uncooperative patients will be excluded.
5. Intervention: In addition to standard treatment, patients in drug / placebo group will receive 2.5 cc Magnesium Sulfate Vial 20% (Manufactured by Pasteur institute, IRC code: 1228054884) by nebulizer mask or 2.5 cc Sodium Chloride 0.9% (manufactured by Samen co. IRC code:1228065256) respectively.
6. Main outcome measures (variables): just before taking drug/placebo and again 90 minutes after that, the following variables will be checked: Lung volumes, Arterial oxygen saturation of hemoglobin and Persian version of CAT questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016012420024N3
Registration date:2016-02-06, 1394/11/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-06, 1394/11/17
Registrant information
Name
Soheil Peiman
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9922
Email address
s-peiman@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2016-01-22, 1394/11/02
Expected recruitment end date
2016-03-22, 1395/01/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of adjunctive nebulized magnesium sulfate on symptoms and lung volumes, in patients presenting with acute exacerbation of chronic obstructive pulmonary disease
Public title
Nebulized magnesium sulfate treatment in acute exacerbation of chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Known history of chronic obstructive pulmonary disease (COPD) based on previous clinical history and spirometry;
2. Presentating to emergency department with at least two of following symptoms: shortness of breath, increase in the amount of sputum and/or purulent pattern of the sputum;
3. Age>40 years;
4. within 24 h of hospital admission;
5. smoking history > 20 pack.year;
Exclusion Criteria:
1. Patient with unstable vital signs;
2. Intubated patient;
3. Associated comorbidity (pneumothorax, pulmonary embolism, pneumonia, acute coronary syndrome, congestive heart failure, neuromuscular disease, active malignancy and etc.);
4. Unconscious patient;
5. Inability to perform spirometry;
6. Nursing/pregnant women;
7. Previous history of allergy to magnesium sulfate;
Age
From 40 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tehran University of Medical Sciences
Street address
6th floor,Vice Chancellor for Research, Tehran University of Medical Sciences central building, Keshavarz blvd. Ghods street.
City
Tehran
Postal code
Approval date
2015-01-03, 1393/10/13
Ethics committee reference number
9111160025-129558
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease with acute exacerbation
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Primary outcomes
1
Description
Lung volumes
Timepoint
Just before the Magnesium Sulfate/Placebo and again after 90 minutes of administration
Method of measurement
COSMED spirometer
2
Description
Arterial oxygen saturation of hemoglobin
Timepoint
Just before the Magnesium Sulfate/Placebo and again after 90 minutes of administration
Method of measurement
Pulse oximeter - Beurer
3
Description
COPD Assessment Test (CAT) questionnaire, persian version
Timepoint
Just before the Magnesium Sulfate/Placebo and again after 90 minutes of administration
Method of measurement
CAT score
Secondary outcomes
1
Description
Duration of hospitalization
Timepoint
Discharge documents
Method of measurement
Days of admission
Intervention groups
1
Description
- Drug: 2.5 cc Magnesium Sulfate Vial 20% (Manufactured by Pasteur institute, IRC code: 1228054884) by nebulizer mask, just after performing the tests,
Category
Treatment - Drugs
2
Description
- Placebo:2.5 cc Sodium Chloride 0.9% (manufactured by Samen co. IRC code:1228065256)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imamkhomeini hospital, Tehran University of Medical Sciences
Full name of responsible person
Dr. Soheil Peiman
Street address
Gharib Street, End of Keshavarz blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Ali Javad Mousavi
Street address
6th Floor, Central organization of Tehran university of medical sciences, Ghods street, Keshavaez blv, Tehran Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Internal medicine, Tehran university of medical sciences
Full name of responsible person
Dr. Soheil Peiman
Position
Assistant professor
Other areas of specialty/work
Street address
Dr Nafissi's Building, Imamkhomeini hospital complex, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 6693 9922
Fax
Email
s-peiman@tums.ac.ir; soheil_peiman@yahoo.com;
Web page address
http://www.tums.ac.ir/faculties/s-peiman
Person responsible for scientific inquiries
Contact
Name of organization / entity
Advanced Thoracic Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr. Besharat Rahimi
Position
Assistant professor
Other areas of specialty/work
Street address
Advanced Thoracic Research Cente, Imamkhomeini medical complex, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 6658 1594
Fax
Email
besharatrahimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Internal medicine, Tehran University of Medical Sciences
Full name of responsible person
Dr. Soheil Peiman
Position
Assistant professor
Other areas of specialty/work
Street address
Dr. Nafissi building, ImamKhomeini hospital, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 21 6693 9922
Fax
Email
Web page address
http://www.tums.ac.ir/faculties/s-peiman
Sharing plan
Deidentified Individual Participant Data Set (IPD)