Determining the effect of cooling the patient with different degrees on blood sugar levels in open heart surgery
Design
Patients will be divided into two groups so that the temperature of one group will reach 30 degrees Celsius and the temperature of the other group will reach 34 degrees Celsius. At the target temperature of group 1 to 30 degrees Celsius and group 2 to 34 degrees Celsius, finally before the patient warms up, blood sugar will be measured and recorded again and blood sugar values in two groups of 30 degrees Celsius and 34 degrees Celsius will be compared.
Settings and conduct
Patients will be divided into two groups so that the temperature of one group will reach 30 degrees Celsius and the temperature of the other group will reach 34 degrees Celsius. At the target temperature of group 1 to 30 degrees Celsius and group 2 to 34 degrees Celsius, finally before the patient warms up, blood sugar will be measured and recorded again and blood sugar values in two groups of 30 degrees Celsius and 34 degrees Celsius will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Patient informed consent
Patients undergoing coronary artery bypass grafting (CABG) and heart valve surgery.
• Non-diabetic patients
• Patients with normal fasting blood sugar (up to 100 mg / dL)
Criteria for not entering:
Patients undergoing CABG without a cardiopulmonary pump.
• Diabetic patients
• Patients with abnormal fasting sugar (more than 100 mg / dL)
Intervention groups
The temperature of one group will reach 30 degrees Celsius and the temperature of the other group will reach 34 degrees Celsius
Main outcome variables
Temperature,Blood sugar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220404054406N1
Registration date:2022-04-17, 1401/01/28
Registration timing:registered_while_recruiting
Last update:2022-04-17, 1401/01/28
Update count:0
Registration date
2022-04-17, 1401/01/28
Registrant information
Name
fatemeh mohammadi shahrestanaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3322 9222
Email address
mohammadifatemeh63813@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-10, 1401/01/21
Expected recruitment end date
2022-05-11, 1401/02/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of different patient cooling on blood sugar in open heart surgery
Public title
The effect of different patient cooling on blood sugar in open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patient informed consent
Patients undergoing coronary artery bypass grafting (CABG) and heart valve surgery.
Non-diabetic patients
Patients with normal fasting blood sugar (up to 100 mg / dL)
Exclusion criteria:
Patients undergoing CABG surgery without a cardiopulmonary pump.
Diabetic patients
Patients with abnormal fasting blood sugar (more than 100 mg / dL)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The person who will analyze the data will not know which group is 30 degrees and which group is 34 degrees.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences and Health Services, hezar jarib Ave
City
isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-03-29, 1401/01/09
Ethics committee reference number
IR.MUI.MED.REC.1401.001
Health conditions studied
1
Description of health condition studied
Blood sugar status
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
blood sugar
Timepoint
Before cardiopulmonary bypass, patients begin to cool down and reach the target temperature of group 1 to 30 ° C and group 2 to 34 ° C, before the patient warms up
Method of measurement
Glucometer device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The temperature will be raised to 30 degrees. Patients' blood sugar once before cardiopulmonary bypass, then when the patients start to cool down and reach the target group temperature of 1 to 30 degrees Celsius, and finally before the patient warms up again. Blood will be measured and recorded and blood sugar values will be compared in two groups of 30 ° C and 34 ° C. Device used to measure blood sugar: glucometer. Number of times 16 times
Category
Prevention
2
Description
Intervention group: The temperature will be raised to 34 degrees. Patients' blood sugar once before cardiopulmonary bypass, then when the patients start to cool down and reach the target group temperature of 1 to 34 degrees Celsius, and finally before the patient warms up again. Blood will be measured and recorded and blood sugar values will be compared in two groups of 30 ° C and 34 ° C. Device used to measure blood sugar: glucometer. Number of times 16 times
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Chamran Martyr Heart Specialized Hospita
Full name of responsible person
Fatemeh Mohammadi Shahrestanaki
Street address
Isfahan - Bozorgmehr Square, third Mushtaq Street, after the city bridge
City
Isfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
mohammadifatemeh63813@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi Shahrestanaki
Street address
Hezar Jerib St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
mohammadifatemeh63813@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi Shahrestanaki
Position
perfusionist
Latest degree
Master
Other areas of specialty/work
perfusion technology
Street address
naderi
City
qazvin
Province
Qazvin
Postal code
3418799688
Phone
+98 28 3322 9222
Email
mohammadifatemeh63813@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi Shahrestanaki
Position
perfusionist
Latest degree
Master
Other areas of specialty/work
perfusion technology
Street address
naderi
City
qazvin
Province
Qazvin
Postal code
3418799688
Phone
+98 28 3322 9222
Email
mohammadifatemeh63813@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi Shahrestanaki
Position
perfusionist
Latest degree
Master
Other areas of specialty/work
perfusion technology
Street address
naderi
City
qazvin
Province
Qazvin
Postal code
3418799688
Phone
+98 28 3322 9222
Email
mohammadifatemeh63813@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available