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Protocol summary
کارآزمایی بالینی تصادفی دو سویه کور ،حجم نمونه120 نفر،فاز2-3
کارآزمایی بالینی تصادفی دو سویه کور ،حجم نمونه120 نفر،فاز3
کارآزمایی بالینی تصادفی دو سویه کور ،حجم نمونه120 نفر،فاز2-3فاز3
Chamran and Nemazi Hospital
Namazi and alzahra heart Hospital
ChamranNamazi and Nemazialzahra heart Hospital
بیمارستان چمران ونمازی
بیمارستان نمازی و قلب الزهرا
بیمارستان چمران ونمازینمازی و قلب الزهرا
سطح سرمی تروپونین یک؛ سطح سرمی سی پی کی ام بی (CPKMB)
سطح سرمی تروپونین آی ؛ سطح سرمی سی پی کی ام بی (CPKMB)
سطح سرمی تروپونین یکآی ؛ سطح سرمی سی پی کی ام بی (CPKMB)
General information
40
30
4030
2-3
3
2-3
نقش محلول کاردیوپلژی حاوی پروپوفل بررویی بیومارکرهای اسیب قلبی
نقش محلول کاردیوپلژی حاوی پروپوفل برروی بیومارکرهای اسیب قلبی
نقش محلول کاردیوپلژی حاوی پروپوفل برروییبرروی بیومارکرهای اسیب قلبی
Primary outcomes
#1
سطح سرمی تروپونین یک
سطح سرمی تروپونین آی
سطح سرمی تروپونین یکآی
Recruitment centers
#1
Name of recruitment center - English: Nemazi Hospital and Alzahra Heart Hospital
Name of recruitment center - Persian: بیمارستان نمازی و بیمارستان قلب الزهرا
Full name of responsible person - English: Golam ali Heidari kochi
Full name of responsible person - Persian: غلامعلی حیدری کوچی
Street address - English: Hazrat vali asr Hospital
Street address - Persian: بیمارستان حضرت ولی عصر
City - English: Fasa
City - Persian: فسا
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7461477587
Phone: +98 71 5336 2449
Fax:
Email: perfusion.heidari@yahoo.com
Web page address:
Name of recruitment center - English: Nemazi Hospital and Alzahra Heart Hospital
Name of recruitment center - Persian: بیمارستان نمازی و بیمارستان قلب الزهرا
Full name of responsible person - English: Gholam ali Heidari kochi
Full name of responsible person - Persian: غلامعلی حیدری کوچی
Street address - English: Hazrat vali asr Hospital
Street address - Persian: بیمارستان حضرت ولی عصر
City - English: Fasa
City - Persian: فسا
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7461477587
Phone: +98 71 5336 2449
Fax:
Email: perfusion.heidari@yahoo.com
Web page address:
Name of recruitment center - English: Nemazi Hospital and Alzahra Heart Hospital Name of recruitment center - Persian: بیمارستان نمازی و بیمارستان قلب الزهرا Full name of responsible person - English: GolamGholam ali Heidari kochi Full name of responsible person - Persian: غلامعلی حیدری کوچی Street address - English: Hazrat vali asr Hospital Street address - Persian: بیمارستان حضرت ولی عصر City - English: Fasa City - Persian: فسا Province: Fars Country: Iran (Islamic Republic of) Postal code: 7461477587 Phone: +98 71 5336 2449 Fax: Email: perfusion.heidari@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr.younes Ghasemi
Full name of responsible person - Persian: دکتر یونس قاسمی
Street address - English: خیابان زند، طبقه هفتم ساختمان مرکزی دانشگاه علوم پزشکی شیراز، معاونت پژوهشی
Street address - Persian: Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City - English: Shiraz
City - Persian: شیرازt
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134844119
Phone: +98 71 3647 4270
Fax:
Email: drtabib.maryam@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr Younes Ghasemi
Full name of responsible person - Persian: دکتر یونس قاسمی
Street address - English: Vice chancellor of research, 7th floor of central building of Shiraz University of Medical Sciences, Zand street
Street address - Persian: خیابان زند، طبقه هفتم ساختمان مرکزی دانشگاه علوم پزشکی شیراز، معاونت پژوهشی
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Country: Iran (Islamic Republic of)
Postal code: 7134844119
Phone: +98 71 3647 4270
Fax:
Email: drtabib.maryam@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr.younesDr Younes Ghasemi Full name of responsible person - Persian: دکتر یونس قاسمی Street address - English: Vice chancellor of research, 7th floor of central building of Shiraz University of Medical Sciences, Zand street Street address - Persian: خیابان زند، طبقه هفتم ساختمان مرکزی دانشگاه علوم پزشکی شیراز، معاونت پژوهشی Street address - Persian: Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street City - English: Shiraz City - Persian: شیرازtشیراز Province: Fars Country: Iran (Islamic Republic of) Postal code: 7134844119 Phone: +98 71 3647 4270 Fax: Email: drtabib.maryam@yahoo.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Golam Ali Heidari kochi
Full name of responsible person - Persian: غلامعلی حیدری کوچی
Position - English: master student of perfusional technology
Position - Persian: دانشجوی کارشناسی ارشد تکنولوژی گردش خون
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Mohammad Rasoul Allah Research Tower, Khalili Street
Street address - Persian: خیابان خلیلی، برج پژوهشی محمد رسول الله، طبقه پنجم
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7134844119
Phone: +98 71 3647 4270
Mobile: +98 917 134 7618
Fax:
Email: drtabib.maryam@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Gholam Ali Heidari kochi
Full name of responsible person - Persian: غلامعلی حیدری کوچی
Position - English: master student of perfusional technology
Position - Persian: دانشجوی کارشناسی ارشد تکنولوژی گردش خون
Latest degree: bachelor
Area of specialty/work: 27
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Mohammad Rasoul Allah Research Tower, Khalili Street
Street address - Persian: خیابان خلیلی، برج پژوهشی محمد رسول الله، طبقه پنجم
City - English: Shiraz
City - Persian: شیراز
Province: Fars
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 7134844119
Phone: +98 71 3647 4270
Mobile: +98 917 134 7618
Fax:
Email: drtabib.maryam@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: GolamGholam Ali Heidari kochi Full name of responsible person - Persian: غلامعلی حیدری کوچی Position - English: master student of perfusional technology Position - Persian: دانشجوی کارشناسی ارشد تکنولوژی گردش خون Latest degree: bachelor Area of specialty/work: 27 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Mohammad Rasoul Allah Research Tower, Khalili Street Street address - Persian: خیابان خلیلی، برج پژوهشی محمد رسول الله، طبقه پنجم City - English: Shiraz City - Persian: شیراز Province: Fars Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 7134844119 Phone: +98 71 3647 4270 Mobile: +98 917 134 7618 Fax: Email: drtabib.maryam@yahoo.com Web page address:
Protocol summary
Study aim
Effect of Propofol Cardioplegia Solution on Myocardial Injury Bio marker in Coronary Artery Bypass Grafting Surgery
Inclusion criteria: patients who are undergoing elective CABG.
Exclusion criteria: Redo operation; emergency CABG for threatened myocardial infarction; Primary troponin level above 3 μg /L; severe renal failure; severe liver failure; congestive heart failure grade IV; Ejection fraction lower than 30%; Food Allergy ( eggs, soy, peanuts).
Intervention groups
Intervention group: Patients in the intervention group received 1200 μg / min propofol by syringe pump as a cardioplegic solution.
Control group: Patients in the control group received cardioplegic solution without adding propofol.
Main outcome variables
serum level of troponin I; serum level of CPKMB
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180922041084N2
Registration date:2019-01-06, 1397/10/16
Registration timing:prospective
Last update:2019-01-24, 1397/11/04
Update count:1
Registration date
2019-01-06, 1397/10/16
Registrant information
Name
Maryam Tabibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1460
Email address
dpt2370349433@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-26, 1397/12/07
Expected recruitment end date
2019-05-28, 1398/03/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Propofol Cardioplegia Solution on Myocardial Injury Bio marker in Coronary Artery Bypass Grafting Surgery
Public title
Effect of Propofol Cardioplegia Solution on Myocardial Injury Bio marker
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient who are candidate for elective Coronary Artery Bypass surgery
Exclusion criteria:
Redo surgery
Primary troponin level is above 3 μg / L
sever Renal failure
sever Liver failure
congestive Heart Failure grade IV
Ejection fraction lower than 30%
Allergy to eggs, soy, peanuts
Age
From 30 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomized according to the charts which was derived from www.randomization.com site.
Blinding (investigator's opinion)
Double blinded
Blinding description
A nurse who is unaware of the study groups will provide the cardioplegic solution and will deliver
cardioplegic solution to the nurse responsible for anesthesia for injection.The investigators in the operation room and in the ward are unaware of the study groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2018-08-23, 1397/06/01
Ethics committee reference number
IR.SUMS.REC.1397.415
Health conditions studied
1
Description of health condition studied
atherosclerosis
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
serum level of troponin I
Timepoint
1st sample just after induction ,2nd sample just after chest closure , 3rd sample 6 hours after arrival to ICU and last sample 24 hours after arrival to the ICU
Method of measurement
Lab test
2
Description
serum level of CPKMB
Timepoint
1st sample just after induction ,2nd sample just after chest closure , 3rd sample 6 hours after arrival to ICU and last sample 24 hours after arrival to the ICU
Method of measurement
Lab test
Secondary outcomes
1
Description
Arhytmia
Timepoint
During operation and after that
Method of measurement
Monitoring
Intervention groups
1
Description
Intervention group:Patients in the intervention group received 1200 μg / min propofol by syringe pump as a cardioplegic solution.
Category
Prevention
2
Description
Control group: Patients in the control group received cardioplegic solution without adding propofol .
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazi Hospital and Alzahra Heart Hospital
Full name of responsible person
Gholam ali Heidari kochi
Street address
Hazrat vali asr Hospital
City
Fasa
Province
Fars
Postal code
7461477587
Phone
+98 71 5336 2449
Email
perfusion.heidari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Younes Ghasemi
Street address
Vice chancellor of research, 7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
drtabib.maryam@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Gholam Ali Heidari kochi
Position
master student of perfusional technology
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
drtabib.maryam@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Jouybar
Position
Fellowship of Cardioanesthesiology
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
drtabib.maryam@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Tabibzadeh
Position
General physician
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
5th floor, Mohammad Rasoul Allah Research Tower, Khalili Street
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3647 4270
Email
drtabib.maryam@yahoo.com
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available