comparing tow methodes: custodiol and modified combination with custodiol and its effect on myocardial protection
Design
single blinded randomized clinical trial with parallel group
Settings and conduct
40 patients undergoing CABG were divided into to group; 1: Patients in the intervention group one will receive 15 cc per /kg of cold modified delnido cardioplegia solution with 1000 cc custodiol during 2-4 min with anti-grade method. Patients in the intervention group two will receive 20 cc per/ kg cold custodiol solution during 6-8 min with anti-grade method.
Participants/Inclusion and exclusion criteria
criteria for entering to study: patients under coronary artery bypass graft with ejection fraction below 30 %, redo coronary artery bypass graft surgeries,
coronary artery bypass graft surgery with valve surgery
criteria for exiting from study: emergent surgury, recently myocardial infarction, renal failur
Intervention groups
group; 1: 15cc per kg of cold modified delnido cardioplegia solution with 1000 cc custodiol will injected at period of 2-4 min with antigrade method. 2; 20 cc per kg cold custodiol solution at period of 6-8 min will injected antigradely
Main outcome variables
primary outcome: serum level of CK-MB and Troponin at the induction time, 2 hours after operation and 48 hours after operation .
Secondary outcome : dysrhythmia during and after operation and defibrillation requirement during operation and mortality rate.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190411043239N1
Registration date:2019-05-24, 1398/03/03
Registration timing:prospective
Last update:2019-05-24, 1398/03/03
Update count:0
Registration date
2019-05-24, 1398/03/03
Registrant information
Name
Neda Reihanifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3620 3853
Email address
nedaaa.reihanifard@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-20, 1398/03/30
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the two methods: using custodiol versus combined custodiol and modified delnido on myocardial protection in Cardiac surgeries.
Public title
Comparison of the two methods: using custodiol versus combined custodiol and modified delnido on myocardial protection in Cardiac surgeries.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients under coronary artery bypass graft with ejection fraction below 30 %
Redo coronary artery bypass graft surgeries
Coronary artery bypass graft surgery with valve surgery
Exclusion criteria:
Emergency surgery
Recently myocardial infarction
Renal failure
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
According to the randomized chart which was derived from www.randomization.org
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient and anesthesia nurse who takes venous blood samples in the operating room.and also the nurse who takes the second and third samples in the ICU and the laboratory instructor does not know the type of patient group.
The only person who is aware of the study group is perfusionist who is injected a cardioplegia solution.
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
7185656948
Approval date
2019-02-20, 1397/12/01
Ethics committee reference number
IR.SUMS.REC.1398.124
Health conditions studied
1
Description of health condition studied
artarteriosclerosis
ICD-10 code
I25.10
ICD-10 code description
Atherosclerotic heart disease of native coronary artery without angina pectoris
Primary outcomes
1
Description
Serum level of CK_MB
Timepoint
induction time, 2 h after operation and 48 h after operation
Method of measurement
venus blood sample
2
Description
Serum level of Troponin
Timepoint
induction time, 2 h after operation and 48 h after operation
Method of measurement
venus blood sample
Secondary outcomes
1
Description
cardiac dysrythmia
Timepoint
induction time, 2h after operation and 48 h after operation
Method of measurement
monitoring
Intervention groups
1
Description
Intervention group 1:.Patients in the intervention group one will receive 15 cc per /kg of cold modified delnido cardioplegia solution with 1000 cc custodiol during 2-4 min with anti-grade method
Category
Prevention
2
Description
intervention group2: Patients in the intervention group two will receive 20 cc per/ kg cold custodiol solution during 6-8 min with anti-grade method.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Ordibehesht hospital
Full name of responsible person
Kazem Chabok
Street address
Chamran boulevard, Ordibehesht hospital
City
Shiraz
Province
Fars
Postal code
7189656948
Phone
+98 71 3628 4821
Email
info@ordibeheshthospital.ir
2
Recruitment center
Name of recruitment center
Shiraz central hospital
Full name of responsible person
Mohamad Reza Khoshnood
Street address
Chamran boulevard, Shiraz Central hospital
City
Shiraz
Province
Fars
Postal code
7189656948
Phone
+98 71 3628 4411
Email
Astalavish@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
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
7189678548
Phone
+98 71 3230 5410
Email
vcrdep@sums.ac.ir
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
Neda reihanifard
Position
Cardiac perfusionist /student
Latest degree
Bachelor
Other areas of specialty/work
Cardiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7189656948
Phone
+98 71 3620 3853
Email
nedaaa.reihanifard@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohamad hasan Nemati
Position
cardiac surgon
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7189656948
Phone
+98 71 3484 4119
Email
nemati_mhs@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Neda Reihanifard
Position
Cardiac perfusionist/ student
Latest degree
Master
Other areas of specialty/work
Cardiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
71896569487
Phone
+98 71 3620 3853
Email
nedaaa.reihanifard@gmail.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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available