Study of the effect of intravenous magnesium sulfate on clinical performance as a complementary therapy of the patients with COPD in the emergency department
This study want to determine the effect of intravenous magnesium sulfate in controlling the acute attack caused by chronic obstructive pulmonary disease (COPD) in patients referred to the emergency department of Imam Khomeini Hospital during a six-hour period.
Design
Randomized, double blind, controlled with placebo, single-centered, phase 3 of trial
Settings and conduct
Patients with chronic pulmonary obstruction with acute attack are examined at the time of admission, 45 minutes and 6 hours after intervention of primary outcomes and secondary outcomes, including respiratory rate and blood pressure in the emergency department of Imam Khomeini Hospital in Sari. Moreover, the standard treatment of the acute attack starts with intervention. Patients will not be informed about which group they are. Moreover, the pharmacist of the study will code the drugs (codes A, B) without the author's knowledge.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who refer to the emergency department for chronic obstructive pulmonary disease caused by smoking
Non inclusion criteria: Patients who have the need for intubation; Patients who have a history of heart disease;patients who have a low level of consciousness; patients who received intravenous magnesium sulfate within the last 24 hours
Intervention groups
Interventional group:Magnesium sulfate 2% made by Obeidi pharmaceutical company is mixed with 200 ml normal saline and is administered using the peripheral vein through slow intravenous infusion within 20 minutes.
Control group:Normal saline 0.9% (Obeidi factory) is given 100 cc once, under slow using the peripheral vein through slow intravenous infusion.
Main outcome variables
Number of breaths
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150315021480N8
Registration date:2018-05-09, 1397/02/19
Registration timing:registered_while_recruiting
Last update:2018-05-09, 1397/02/19
Update count:0
Registration date
2018-05-09, 1397/02/19
Registrant information
Name
Fatemeh Jahanian
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
fjahanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mazandaran University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of intravenous magnesium sulfate on clinical performance as a complementary therapy of the patients with COPD in the emergency department
Public title
The effect of intravenous magnesium sulfate as a complementary therapy to COPD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with chronic pulmonary obstruction with moderate severity.
Exclusion criteria:
Patients who have the need for intubation.
Patients who have a history of heart disease
Patients who have a low level of consciousness
Patients who received intravenous magnesium sulfate within the last 24 hours
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided to two groups using simple randomization . In this way, we place each patient to toss up a coin head and tail in the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will not be informed of the type of the group they will be. Moreover, the pharmacist of the study will code the drugs (codes A, B) without the author's knowledge. Thus, the nurse and distributor will also be unaware of the name of the drug received.
Placebo
Used
Assignment
Parallel
Other design features
In this study, the randomization of random number table was used.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research, Mazandaran University of Medical Sciences, Moalem Square, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4813656254
Approval date
2017-08-18, 1396/05/27
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1396.2761
Health conditions studied
1
Description of health condition studied
Chronic obstructive pulmonary disease
ICD-10 code
j44
ICD-10 code description
j44
Primary outcomes
1
Description
Number of breaths
Timepoint
Counting the number of breaths at the beginning of the study (before the intervention) and 45 minutes and 6 hours after starting magnesium sulfate
Method of measurement
We count the breath per one minute
Secondary outcomes
1
Description
blood pressure
Timepoint
before intervention and 45 minutes and 6 hours after intervention
Method of measurement
We get blood pressure using a manometer portable .
Intervention groups
1
Description
Intervention group: Magnesium sulfate (2%) Obiidi pharmaceutical company is mixed with 200 ml of normal saline and is given intravenous infusion intravenously in 20 minutes
Category
Treatment - Drugs
2
Description
Control group: Normal saline 0.9% (Obeidi factory) is given 100 cc once, under slow given intravenous infusion intravenously
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital of Sari
Full name of responsible person
Sepideh Amirifar
Street address
Emergency Medicine Department, Imam Khomeini Hospital, Amir Mazandarani Street, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4813656148
Phone
+98 11 3322 1755
Email
bnf.nr70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Ahmad Ali Enayati
Street address
Mazandaran University Of Medical Sciences, The beginning of the highway Valiasser, Joybar Three-way, Imam (AS) square
City
Sari
Province
Mazandaran
Postal code
4813656526
Email
BNF.nr70@gmail.com
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 of Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sepideh Amirifar
Position
Residency Of Emergency Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Emergency Medicine Department, Imam Khomeini Hospital, Amir Mazandarani Street, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4813656148
Phone
+91 11555084
Fax
Email
sepidehamirifard@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Jahanian
Position
Emergency Medicine Spicialist
Latest degree
Specialist
Other areas of specialty/work
Street address
Emergency Medicine Department, Imam Khomeini Hospital, Amir Mazandarani Street, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4813656148
Phone
00
Fax
Email
sepidehamirifard@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Sepideh Amirifar
Position
Residency of Emergency Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Street address
Emergency Medicine Department, Imam Khomeini Hospital, Amir Mazandarani Street, Sari, Iran
City
Sari
Province
Mazandaran
Postal code
4813656148
Phone
+91 11555084
Fax
Email
sepidehamirifard@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data, such as information on the main outcome will be released after the publication of the article.
When the data will become available and for how long
April 2018 to May 2018
To whom data/document is available
Available only to researchers in academic and scientific institutions
Under which criteria data/document could be used
There is no limitation.
From where data/document is obtainable
sepideh amirifard. sepidehamirifard@gmail.com
What processes are involved for a request to access data/document
Send your request to the respondent's email. If the intended article is published, we will share the data with other researchers, but we will not disclose the data before the publication process