Determining and comparing the mean total antioxidant capacity (TAC) in patients in the two groups of remote ischemia induction (RIPC) and the control group
Design
A controlled clinical trial, with parallel groups, double-blinded, randomized, on 50 patients. Excel software rand function was used for randomization.
Settings and conduct
The project is carried out in the heart center of Tehran. The study is a clinical trial with two groups of remote ischemia preconditioning (RIPC) and control. Clinical and laboratory outcomes are performed by physicians and nurse assessors who are blind to the type of intervention. The patient is also unaware of the type of intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Candidate for coronary artery bypass grafting with cardiopulmonary bypass
Normal upper limb examinations
Not having surgical operations in the past three months
Not having acute medical conditions during the last three months
Exclusion criteria:
Known inflammatory disorders
Diabetes
Liver disease
Kidney disease
Receiving vitamins C and/or E and/or other antioxidants
Intervention groups
- Intervention group under RIPC: ischemia by inflating the blood pressure cuff for 5 minutes and 5 minutes of reperfusion by deflating the cuff (4 times).
- Control: No intervention will be performed.
Main outcome variables
Total antioxidant capacity, glutathione peroxidase activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201014049022N1
Registration date:2020-11-15, 1399/08/25
Registration timing:registered_while_recruiting
Last update:2020-11-15, 1399/08/25
Update count:0
Registration date
2020-11-15, 1399/08/25
Registrant information
Name
Fazel Gorjipour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8862 2709
Email address
gorjipour.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of remote ischemic preconditioning (RIPC) on total antioxidant capacity (TAC) patients under coronary artery bypass grafting (CABG)
Public title
Improving oxidant effects following open heart surgery
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for coronary artery bypass grafting with cardiopulmonary bypass
Normal upper limb examinations
Not having surgical operations in the past three months
Not having acute medical conditions during the last three months
Exclusion criteria:
Known inflammatory disorders
Diabetes
Liver disease
Kidney disease
Receiving vitamins C and/or E and/or other antioxidants
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
3
1) The first venous blood sample will be drawn before the blood pressure cuff is closed in order to perform the desired intervention in relation to RIPC and in the control group will be performed at the corresponding time. 2) The second venous blood sample will be drawn after the CPB is completed. 3) The third venous blood sample will be taken 24 hours after ICU admission.
Randomization (investigator's opinion)
Randomized
Randomization description
The studied patients will be divided into two groups of intervention under RIPC and control. We use a simple randomization method for allocating patients into two groups. Each randomization unit is an individual that is assigned with a random number between zero and one using Excel software. Patients with a number greater than or equal to 0.5 are in the RIPC intervention group and the group with a number of less than 0.5 is in the control group. The anesthesiologist and the anesthesia nurse are aware of the group the patient is in and perform the intervention in the RIPC and control groups. The surgeon, the nurse recording the outcomes, and the laboratory expert who performs the laboratory tests have no knowledge of the study groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The anesthesiologist and the anesthesia nurse are aware of the group the patient is in and perform the intervention in the RIPC and control groups. In the next stages, all interventions are similar in both groups, and the surgeon and the nurse recording the outcomes are not aware of the study group. Then, the samples drawn by the anesthesia team are coded confidentially. Therefore, the laboratory expert who performs the laboratory tests have no knowledge 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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qods street cross., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-07-28, 1399/05/07
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.270
Health conditions studied
1
Description of health condition studied
Coronary artery bypass grafting
ICD-10 code
Z95.1
ICD-10 code description
Presence of aortocoronary bypass graft
Primary outcomes
1
Description
Total antioxidant capacity
Timepoint
After anesthesia induction, after cardiopulmonary bypass, 24 hours after intensive care unit admission
Method of measurement
With turbidimetry analysis
2
Description
Glutathione peroxidase activity assay
Timepoint
After anesthesia induction, after cardiopulmonary bypass, 24 hours after intensive care unit admission
Method of measurement
With turbidimetry analysis
Secondary outcomes
1
Description
Troponin level
Timepoint
After anesthesia induction, after cardiopulmonary bypass, 24 hours after intensive care unit admission
Method of measurement
ELISA
2
Description
Ejection fraction
Timepoint
Every 8 hours after intensive care unit admission
Method of measurement
Echocardiography
Intervention groups
1
Description
Intervention group: inflation of the blood pressure cuff for 5 minutes and deflation for 5 minutes with 4 repeats
Category
Treatment - Other
2
Description
Control group: no intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Mehdi Dehghani Firouzabadi
Street address
Tehran Heart Center, North Karegar St., Jalal-e-Al-e-Ahmad cross.
City
Tehran
Province
Tehran
Postal code
1313814117
Phone
+98 21 8802 9600
Email
mdfiroozabadi834@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Central Building of Tehran University of Medical Sciences, Keshavarz Boulevard, corner of Ghods Street
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
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
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farhad Gorjipour
Position
Perfusionist
Latest degree
Master
Other areas of specialty/work
Clinical Perfusion
Street address
Shahid Madani St.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
0098 21 73430
Email
gorjipoorf@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Javad Mehrbanian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
North Karegar, Jalal-e-Al-e-Ahmad cross.
City
Tehran
Province
Tehran
Postal code
1313814117
Phone
+98 21 8802 9600
Email
mehrabanian56@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Fazel Gorjipour
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Iran University of Medical Sciences, Between Sheykh Fazlollah and Chamran highways, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2709
Fax
Email
fgorjipour@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
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