Protocol summary

Summary
This study will evaluate the effect of MgSO4 (as a vasodilator, improving agent for diastolic dysfunction and arrhythmia attenuator) on serum ProBNP (as the indicator of prognosis) in 60 patients who are undergoing coronary artery bypass grafting for the first time. These patients have at least 2 stenotic coronary arteries more that 70% and Ejection Fraction (EF) less than 45%. Patients who present renal failure, history of arrhythmia or need to undergo emergency operation will be excluded. Patients will be allocated to intervention and control group randomly. Intervention group will receive MgSO4 infusion 20mg/kg/hour and control group infusion of Normal Saline as placebo. Serum level of ProBNP and mechanical ventilation time will be the outcome of this study which will be compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205069650N1
Registration date: 2012-06-28, 1391/04/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2012-06-28, 1391/04/08
Registrant information
Name
Ehsan Bastanifar
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2261 5486
Email address
e.bastanifar@gmail.com
Recruitment status
Recruitment complete
Funding source
Anesthesia research center, Shahid Beheshtil Universityof Medical Sciences
Expected recruitment start date
2012-06-30, 1391/04/10
Expected recruitment end date
2012-09-15, 1391/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of magnesium sulfate infusion on blood levels of ProBNP in patients undergoing coronary artery bypass grafting
Public title
The effect of Mg on the cardiac biomarker proBNP
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: significant coronary artery stenosis (2VD or 3VD) and EF<45%. Exclusion criteria: 1.Conduction abnormality (branch block); 2.AF rhythm; 3.Diabetes mellitus. 4.cr>1.8; 5.Emergent surgery; 6.Unstable angina; 7.Redo surgery; 8.Combination surgery (carotid endarterectomy, vulvoplasty); 9.long QT syndrome, neuromuscular junction disorders.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Shahid Beheshtil University of medical sciences
Street address
Velenjak
City
Tehran
Postal code
Approval date
2010-05-23, 1389/03/02
Ethics committee reference number
88011486646

Health conditions studied

1

Description of health condition studied
Atherosclerotic heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
ProBNP
Timepoint
before intervention, 24 hours after intervention
Method of measurement
ELISA based lab kit

Secondary outcomes

1

Description
mechanical ventilation time
Timepoint
days on mechanical ventilation
Method of measurement
questionnaire

Intervention groups

1

Description
Control: infusion of Normal Saline
Category
Placebo

2

Description
Intervention: MgSO4 infusion 20mg/kg/hour
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Modarres hospital
Full name of responsible person
Dr. Mahnoosh Foroughi
Street address
Cardiac research center, Modarres hospital, Saadat abad
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Anesthesiology Research Center, Shahid Beheshtil Universityof medical sciences
Full name of responsible person
ِDr. Hedayat allah Eliasi
Street address
Anesthesiology research center, Shahid Beheshti University of Medical Sciences,Taleghani hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthesiology Research Center, Shahid Beheshtil Universityof 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
Shahid Beheshtil Universityof Medical Sciences
Full name of responsible person
Dr. Mahnoosh Foroughi
Position
Assistant Professor
Other areas of specialty/work
Street address
Cardiac research center, Modarres hospital
City
Tehran
Postal code
Phone
+98 21 2208 3106
Fax
+98 21 2208 3106
Email
mahnoosh.foroughi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshtil Universityof Medical Sciences
Full name of responsible person
Dr. Mahnoosh Foroughi
Position
assistant professor
Other areas of specialty/work
Street address
Cardiac research center, Modarres hospital
City
Tehran
Postal code
Phone
+98 21 2208 3106
Fax
+98 21 2208 3106
Email
mahnoosh.foroughi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshtil Universityof Medical Sciences
Full name of responsible person
Dr. Mahnoosh Foroughi
Position
Assistant Professor of cardiac surgery
Other areas of specialty/work
Street address
Cardiac research center, Modarres hospital
City
Tehran
Postal code
Phone
+98 21 2208 3106
Fax
+98 21 2208 3106
Email
mahnoosh.foroughi@gmail.com
Web page address

Sharing plan

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