The effect of retrograde autologous priming on anion gap of blood transfusion and glomerular filtration rate in coronary artery bypass grafting
Design
An interventional and random study will be conducted in two groups of 70 with a sample size of 140, double-blind and randomized in completely separate groups.
Settings and conduct
In this study, with a total sample size of 140 patients in a double-blind randomized clinical trial who undergo coronary heart surgery at Abu Ali Sinai Hospital in Shiraz, after the patients are under general anesthesia after skin preparation and sterilization, surgery with a median sternotomy approach, and heart and lung cannulation and After injecting 400 units/kg of heparin, they are connected to the cardiopulmonary pump, in the intervention group, 500 ml of the patient's blood is retrogradely replaced by 500 ml of the prime solution.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consentو Patients 45 to 80 years old, Candidate patients for coronary artery surgery. Exclusion criteria: Acute infection, Steroid users, Vascular problems
Intervention groups
Intervention group 1 (case ) After the patients are under general anesthesia, skin preparation, and surgical sterilization, with a median sternotomy approach and heart and lung cannulation. After injecting 400 U/KG of heparin, they are connected to the cardiopulmonary pump. In the tested group, 500 ml of the patient's blood is retrogradely replaced by 500 ml of the prime solution. Control group: After priming the oxygenator in the usual way using 1500 ml of Ringer's solution, pulseless blood flow with a flow of 2-2.4 liters per minute per square meter with an average decrease in temperature (32-34 centimeters) Grad) starts.
Main outcome variables
Arterial Blood Gas
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180922041084N8
Registration date:2022-10-11, 1401/07/19
Registration timing:prospective
Last update:2022-10-11, 1401/07/19
Update count:0
Registration date
2022-10-11, 1401/07/19
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
2022-11-21, 1401/08/30
Expected recruitment end date
2023-07-23, 1402/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of retrograde autologous priming on anion gap of blood transfusion and glomerular filtration rate in coronary artery bypass grafting
Public title
The effect of retrograde autologous priming on anion gap of blood transfusion and glomerular filtration rate in coronary artery bypass grafting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Patients 45 to 80 years old
Candidate patients for coronary artery surgery
Exclusion criteria:
Patients with physical conditions higher than grade 3, based on the classification of the American Society of Anesthesiologists(ASA>3)
Acute infection
Steroid users
Vascular problems
Non-sinusoidal rhythm
Complete branch block
Myocardial infarction
Recent third-degree block (in the last month)
Severe pulmonary disease (based on the doctor's opinion and the use of pulmonary drugs)
Kidney disorders (creatinine more than 1.5)
Hematocrit less than 30%
Discharge fraction less than 40%
Age
From 45 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
140
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the limited randomization method of the block randomization type. The size of all the blocks is the same. In this experiment, with a sample size of 140, we will have two groups of 70 blocks (including 35 blocks with a size of 4). The randomization list is also taken from the random sequence generation site www.sealedenvelope.com, which can generate a random sequence using the blocking method. The allocation ratio of the samples will be one to one and placed in two intervention groups 1 and the control group. Then, based on the obtained blocks and in the order of the allocation sequence, the necessary technology will be given to the patients. This study is double-blind
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double-blind, so that the patient and the personnel collecting information are unaware of the type of intervention in these patients.
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
7th floor, research assistant of Shiraz University of Medical Sciences, central building of Shiraz University of Medical Sciences, Zand St.
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2022-08-14, 1401/05/23
Ethics committee reference number
IR.SUMS.MED.REC.1401.234
Health conditions studied
1
Description of health condition studied
Coronary heart disease
ICD-10 code
I25.118
ICD-10 code description
Atherosclerotic heart disease of native coronary artery with other forms of angina pectoris
Primary outcomes
1
Description
Atrial Fibrillation
Timepoint
The patient's ECG is evaluated before - during - after the opening of the aortic clamp and the start of heart contraction until the last day of the patient's hospitalization in the ICU.
Method of measurement
Through ECG monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Under general anesthesia, after skin preparation and surgical sterilization, with a median sternotomy approach and heart and lung cannulation, and after injecting 400 units/kg of heparin, they are connected to the cardiopulmonary pump. In group 1, we replace 500 ml of prime solution with 500 ml of the patient's blood in a retrograde manner.
Category
Treatment - Surgery
2
Description
Control group: For the patients in the control group, the standard method is used, in this method, after priming the oxygenator in the usual way, using 1500 ml of Ringer's solution, pulseless blood flow with a flow of 2-2.4 liters per minute per meter square) starts with a moderate decrease in temperature (32-34 centigrade). First, we start the pump slowly and then we remove the clamp on the Venus cannula so that the venous blood enters the oxygenator and then we increase the flow rate to normal.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Ali Sina Hospital
Full name of responsible person
Seyedeh Toktam Seyedhoseyni
Street address
The new city of Sadra is the beginning of phase two
City
Shiraz
Province
Fars
Postal code
71994_67985
Phone
+98 71 3640 7063
Email
Otc.hospital@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Mahtab Memarpoor
Street address
7th floor, research assistant of Shiraz University of Medical Sciences, central building of Shiraz University of Medical Sciences, Zand St
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3235 7282
Email
memarpour@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
Seyedeh Toktam Seyedhoseyni
Position
licensee
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4270
Email
toktam.seyedhoseyni@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Reza Joybarr
Position
Assistant Professor of Anesthesiology, Cardiac Anesthesiology Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3647 4270
Email
joybarr@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
MaryamTabibzadeh
Position
Medical Doctor
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Province
Fars
Postal code
07193635899
Phone
+98 71 3647 4270
Email
drtabib.maryam@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is against the policies of our center.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available