Determining the effect of acute normovolemic blood dilution on the function of vital organs in patients who are candidates for heart surgery
Design
A controlled, parallel-group, triple-blinded, randomized clinical trial on 60 patients. Randomized Block Design method was used for randomization.
Settings and conduct
In the intervention group, one unit of blood is taken from adult patients who are candidates for heart surgery with hemoglobin greater than or equal to 14 after general anesthesia. In the control group, there are patients who are candidates for heart surgery with hemoglobin greater than or equal to 14, and we only perform routine heart surgery interventions. The place of study will be Chamran Hospital, Isfahan. Patients, researchers and analysts are not aware of the patient group.
Participants/Inclusion and exclusion criteria
The participants of the study are adult patients who are candidates for heart surgery with hemoglobin greater than or equal to 14.
Intervention groups
In the intervention group, one unit of blood is taken from adult patients who are candidates for heart surgery with hemoglobin greater than or equal to 14 after general anesthesia. Blood sampling is done through an arterial catheter that is implanted for the purpose of invasive blood pressure measurement.
In the control group, there are patients who are candidates for heart surgery with hemoglobin greater than or equal to 14, and we only perform routine heart surgery interventions.
Main outcome variables
Renal function and respiratory function of the patient 48 hours after the operation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230508058118N1
Registration date:2023-11-05, 1402/08/14
Registration timing:registered_while_recruiting
Last update:2023-11-05, 1402/08/14
Update count:0
Registration date
2023-11-05, 1402/08/14
Registrant information
Name
Amirreza Mojganian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3521 3457
Email address
amirreza75mojganian@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-05, 1402/08/14
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of acute normovolemic blood dilution on the function of vital organs in patients who are candidates for heart surgery
Public title
Investigating the effect of acute normovolemic blood dilution on the function of vital organs in patients who are candidates for heart surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients candidates for heart surgery
Ejection fraction more than 40%
Hemoglobin greater than and equal to 14
No kidney, liver, respiratory or brain failure
Exclusion criteria:
Pump time more than 120 minutes
Use of circulatory arrest
Reoperation due to surgical bleeding
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This stage will be by randomized block design method. At this stage, patients will be divided into 2 blocks (30 blocks of 2). Then they are sorted according to the national code (the larger national code of the first row of the block and the smaller national code of the second row of the block). After that, we refer to the table of random numbers for each block. If the selected number was from 0 to 4, the patient in the first row will join group A and the patient in the second row will join group B. If the selected number is from 5 to 9, the patient in the first row will join group B and the patient in the second row will join group A. After 30 patients of group A and 30 patients of group B were determined, group A will be the intervention group and group B will be the control group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient, all study investigators and data analyzers were blinded to patient grouping. The patient is unconscious during the intervention, and the study researchers (data collectors) and data analyzers are unaware of the intervention.
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
Vice Chancellor for Research and Technology, Hezar Jerib St.sfahan University of MedicalSciences and Health Services, Building No. 4
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-11-10, 1401/08/19
Ethics committee reference number
IR.MUI.MED.REC.1401.288
Health conditions studied
1
Description of health condition studied
Coronary artery bypass surgery
ICD-10 code
I97.190
ICD-10 code description
Other postprocedural cardiac functional disturbances following cardiac surgery
Primary outcomes
1
Description
Postoperative renal function
Timepoint
24 and 48 hours after the operation
Method of measurement
Creatinine and blood urea nitrogen test
2
Description
Postoperative pulmonary function
Timepoint
24 and 48 hours after the operation
Method of measurement
Venous blood gas test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Storing the blood of patients before the operation and injecting it after the operation
Category
Rehabilitation
2
Description
Control group: Routine open heart surgery
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital, Isfahan
Full name of responsible person
Seyyed Alireza Hosseini
Street address
Chamran Hospital, After Shahristan Bridge, Salman Farsi St
City
Isfahan
Province
Isfehan
Postal code
8158388997
Phone
+98 31 3260 0961
Email
education@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Vice Chancellor for Research and Technology, Hezar Jerib St.sfahan University of Medical Sciences and Health Services, Building No. 4
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
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
Amirreza Mozhganian
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
amirreza75mojganian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amirreza Mozhganian
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
amirreza75mojganian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amirreza Mozhganian
Position
Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Alzahra Hospital, Sofeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
amirreza75mojganian@gmail.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
Information is kept confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Yes - There is 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
Not applicable
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
After publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Using data to complete studies
From where data/document is obtainable
Isfahan University of Medical Sciences, Amirreza Mozhganian
What processes are involved for a request to access data/document
By examining the researcher's request and providing sufficient documentation of his research and the reason for using the data can be provided.