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Evaluation of the protective effect of MGSO4 in Equation of the motion and lung inflammation following Amiodarone infusion in stroke

Protocol summary

Summary
Purpose: Evaluation of the protective effect of MGSO4 in Equation of the motion and lung inflammation following Amiodarone infusion in stroke. Design: This is a Randomized Controlled Clinical Trial Double Blind Prospective study that will be performed in one year interval in Sina and Baqiyatallah hospital. The patients will be assigned randomly to two groups after the consent form sign by a family member. Setting and conduct: The patients with confirmed stroke (by CT scan) will receive Amiodarone 300 mg as a bolus then 50 mg/hrs for 5 days. In the treatment group 15 cc (7.5 mg) of magnesium sulfate will be infused daily to each patient. In the control group 15 cc of placebo will be infused to each patient. Participant: The patients with confirmed stroke that consent form was signed by a family member and the patients who had atrial fibrillation and undergo treatment with amiodarone will be included in the study. Patients with Serum creatinine exceeding 2 mg/dl and presence of Hypermagnasemia will be excluded from the study. Intervention: Infusion of Magnesium sulfate to the intervention group and placebo to the control group. Main outcome measure: Measurement of MODS, APACHE II ,SOFA Score, Morbidity, Mortality ALT. AST. BUN, SCr, PH, Lactate, Total Bllirubin, Na, K, WBC, PLT, Hb IL6 IL8 SNSE S100B PAF PAI CAM 1 Elastin Fiber E-Selectin NGAL EGF TGF IgA IgG , FRC TLC MIV RV MVV , NIHSS and GCS before and after the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201701011165N16
Registration date: 2017-01-29, 1395/11/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-01-29, 1395/11/10
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor of research of Tehran university of medical sciences
Expected recruitment start date
2016-12-15, 1395/09/25
Expected recruitment end date
2017-12-16, 1396/09/25
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Evaluation of the protective effect of MGSO4 in Equation of the motion and lung inflammation following Amiodarone infusion in stroke
Public title
Evaluation of the protective effect of MGSO4 in Equation of the motion and lung inflammation following Amiodarone infusion in stroke
Purpose
Treatment
Inclusion/Exclusion criteria
_Inclusion criteria: stroke confirmed by CT scan; Consent form was signed by family member; The patient was undergo treatment with amiodarone; The patient had Atrial fibrilation _Exclusion criteria: Serum creatinin greater than 2 mg/dl; Hypermagnasemia occur in the patient; The patient do not receive treatment for more than 24 hours.
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Groups are randomly assigned to intervention and control group using blocks of four random design.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of medical sciences
Street address
Mollasadra St - Sheikh bahaee
City
Tehran
Postal code
Approval date
2016-12-12, 1395/09/22
Ethics committee reference number
IR.BMSU.REC.1395.88

Health conditions studied

1

Description of health condition studied
Stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction

Primary outcomes

1

Description
Infarct size
Timepoint
Before and after of intervention
Method of measurement
CT Scan

2

Description
Immunoglobulin G, Immunoglobulin A, S100B Protein, SNSE Protein
Timepoint
Before and after of intervention
Method of measurement
Elisa Kit

Secondary outcomes

1

Description
Mortality, Vascular resistance, Delirium, Mechanical ventilation index, Multi-Organ Dysfunction Score, APACHE II Score, SOFA Score, Candida Score, Hospitalization Period
Timepoint
Before and after of intervention
Method of measurement
Questionnaire

2

Description
White blood cell count, platelet count, Hemoglobin, Alanine transaminase, Aspartate transaminase, Serum Creatinine, Serum Potassium, Serum Natrium, Serum Lactate, Total Serum Bilirubin, Blood PH
Timepoint
Before and after of intervention
Method of measurement
Blood and Serum Analysis

3

Description
Interleukin 6, Interleukin 8, Platelet-activating factor, Plasminogen activator inhibitor-1, CAM-1 Protein, Elastin Fiber Protein, E-Selectin Protein, NGAL Protein, EGF Protein, TGF Protein
Timepoint
Before and after of intervention
Method of measurement
Elisa Kit

4

Description
Functional Residual Capacity, Respiratory Rate, Total Lung Capacity, Vital Capacity, Residual Volume, (Maximum Ventilatory Volume, Forced Expiratory Volume
Timepoint
During the study
Method of measurement
Ventilator

5

Description
Glasgow Coma Scale, National Institutes of Health Stroke Scale
Timepoint
During the study
Method of measurement
Questionnaire

Intervention groups

1

Description
Treatment group will receive 7.5 gr (15 cc) of magnesium sulfate SID for 5 days.
Category
Treatment - Drugs

2

Description
control group will receive 15 cc of placebo SID for 5 days.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Yunes Panahi
Street address
Hassan abad st - imam khomeini St
City
Tehran

2

Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Dr Yunes Panahi
Street address
Mollasadra st - sheikh bahaee st.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of medical sciences (Vice Chancellor of research)
Full name of responsible person
Dr. Masoud Yunesian
Street address
6th floor, Central Organization of U of T, Keshavarz Blvd.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of medical sciences (Vice Chancellor of research)
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
Baqiyatallah University of medical sciences
Full name of responsible person
Yunes Panahi
Position
Professor/ PharmD
Other areas of specialty/work
Street address
Mollasadra St.
City
tehran
Postal code
Phone
+98 21 8248 2503
Fax
Email
yunespanahi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
baiyatallah university of medical sciences
Full name of responsible person
Yunes Panahi
Position
Professor/ PharmD
Other areas of specialty/work
Street address
Mollasadra St. Sheikh bahaee st.
City
Tehran
Postal code
Phone
+98 21 8248 2503
Fax
Email
Yunespanahi@yahoo.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
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Analytic Code
empty
Data Dictionary
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