The aim of this study was to investigate the effects of acute magnesium IV loading on improving dyspnea in patients with acute COPD exacerbation referred to the emergency department of Imam Reza hospital during February and July 2015.
In this randomised double-blind placebo-controlled trial study, 72 patients with exacerbated COPD undergo baseline peak-flow-metry and are subsequently randomized to 2 groups in a double-blind design. All patients receive routine treatment of COPD exacerbation and patients in the case group receive 2 grams of intravenous magnesium sulfate in 100cc normal saline, patients in control group receive 100cc normal saline.
Peak-flow-metry is performed 15, 30, and 45 minutes after administration of magnesium sulfate or placebo and patient are asked about severity of dyspnea based on the 5 point likert scale. Primary outcomes are subjective improvement of dyspnea, improvement of peak-flow-metry measurements, tracheal intubation in the period of admission and length of stay in the emergency department.
Inclusion criteria was any patient older than 18 years old with acute exacerbation of COPD and exclusion criteria were any other underlying causes for dyspnea including heart failure, asthma, renal failure, pneumothorax, pneumonia …
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014111519962N1
Registration date:2015-02-04, 1393/11/15
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2015-02-04, 1393/11/15
Registrant information
Name
Elham Pishbin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 5312
Email address
pishbine@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Mashhad University of Medical Sciences
Expected recruitment start date
2015-01-30, 1393/11/10
Expected recruitment end date
2015-08-01, 1394/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of IV magnesium sulfate on dyspnea improving of acute COPD exacerbation
Public title
The effect of IV magnesium sulfate on dyspnea improving of patients with chronic obstructive pulmonary disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria was any patient older than 18 years old with acute exacerbation of COPD and exclusion criteria were any other underlying causes for dyspnea including heart failure, asthma, renal failure, pneumothorax, pneumonia …
Age
From 18 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
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
Mashhad University of Medical Sciences
Street address
Daneshgah Ave. Ghoreyshi building
City
Mashhad
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
922741
Health conditions studied
1
Description of health condition studied
Chronic Obstructive Pulmonary Disease
ICD-10 code
J44.1
ICD-10 code description
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Primary outcomes
1
Description
subjective improvement of dyspnea
Timepoint
15, 30, and 45 minutes after administration of magnesium sulfate or placebo
Method of measurement
patient are asked about severity of dyspnea based on the 5 point likert scale
2
Description
Peak Expiratory Flow Rate(PEFR) improvement
Timepoint
15, 30, and 45 minutes after administration of magnesium sulfate or placebo
Method of measurement
Peak-flow-metry
Secondary outcomes
1
Description
Intubation during the course of admition
Timepoint
any time during first 12 hours of admition
Method of measurement
Based on patients records
2
Description
length of hospital stay
Timepoint
time of discharge from hospital
Method of measurement
Based on patients records
Intervention groups
1
Description
intervention in control group: receive 100cc normal saline.
Category
Treatment - Drugs
2
Description
intervention in case group: infusion of 2 grams of Mgso4 in 100 cc normal saline in 20 minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Elham Pishbin
Street address
Imam Reza squer , Ibn e Sina street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chanceller for research of Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad - Daneshgah Ave. - Mashhad University of Medical Sciences-Vice Chanceller for research
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chanceller for research of Mashhad 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
Mashhad University of Medical Sciences - Imam Reza hospital
Full name of responsible person
Elnaz Vafadar Moradi
Position
Emergency medicine resident
Other areas of specialty/work
Street address
Imam Reza Square- Ibne e Sina street
City
Masshah
Postal code
Phone
+98 51 3852 5312
Fax
Email
elnaz.vafadar@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences - Imam Reza hospital
Full name of responsible person
Elham Pishbin
Position
Assistant Professor of Emergency medicine
Other areas of specialty/work
Street address
Imam Reza squer , Ibn e Sina street
City
Mashhad
Postal code
9137913316
Phone
+98 51 3852 5312
Fax
+98 51 3852 5312
Email
pishbine@mums.ac.irelham_pishbin@yahoo.com
Web page address
http://www.mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences - Imam Reza hospital
Full name of responsible person
Elnaz Vafadar Moradi
Position
Emergency medicine resident
Other areas of specialty/work
Street address
Imam Reza Square- Ibne e Sina street
City
Mashhad
Postal code
Phone
+98 51 3852 5312
Fax
Email
elnaz.vafadar@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)