Evaluation of clinical results and level of interleukin 6 using 20% albumin in comparison with prime valve colloid sample in Coronary artery bypass graft surgery
Clinical Outcomes and Inflammatory Response Using Interleukin 6 Levels after Cardiopulmonary Bypass Using 20% Albumin Compared with Voluven as Primary Colloid Fluid in Coronary Heart Transplant Surgery
Design
A clinical trial with two intervention groups, with parallel groups, non blind, randomized, phase two, was performed on forty patients. A simple method with coin tossing is used for randomization.
Settings and conduct
The study was performed non_blind
The study site was in the operating room of Isfahan Chamran Hospital, using blood sampling and reviewing the patient's clinical results after surgery in the ICU, and finally comparing the results obtained using the two types of primers.
Participants/Inclusion and exclusion criteria
Admission requirements:
Patient age between 40 _75
Ejection fraction> 35%
Non-emergency surgery
Discontinue aspirin and Plavix 48 hours before surgery
Conditions for not entering the study:
Children
Candidates for open heart surgery without using a heart pump device
Patients in the last stage of life
Patients with liver failure
Patients with renal failure
Patients with preoperative infections such as infectious endocarditis
Patients with recent inflammation
Patients with recent myocardial infarction
Intervention groups
The study consists of two intervention groups: the first group of twenty patients who undergo coronary artery bypass graft surgery use 20% albumin as a prime solution during surgery and the second group of twenty patients who undergo coronary artery bypass graft surgery as a prime solution during surgery. We use voluven
Main outcome variables
Interleukin 6
Drainage rate after surgery
The amount of blood product received after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220410054470N1
Registration date:2022-05-02, 1401/02/12
Registration timing:registered_while_recruiting
Last update:2022-05-02, 1401/02/12
Update count:0
Registration date
2022-05-02, 1401/02/12
Registrant information
Name
atefeh hashemabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3601 0583
Email address
ati.hashemabadi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-12, 1401/01/23
Expected recruitment end date
2023-01-13, 1401/10/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical results and level of interleukin 6 using 20% albumin in comparison with prime valve colloid sample in Coronary artery bypass graft surgery
Public title
Evaluation of clinical results and level of interleukin 6 using 20% albumin in comparison with prime voluven colloid sample in CABG surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient age between 40 to 75
Ejection fraction>35٪
Non-emergency surgery
Discontinue aspirin and Plavix 48 hours before surgery
Exclusion criteria:
Children
Candidate patients for cardiac surgery without using cardiopulmonary bypass device
End Stage patients
patients with liver failure
patients with kidney failure
Patients with preoperative infections such as infectious endocarditis
Patients with recent inflammation
Patients with recent MI
Age
From 40 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed in a simple method, the randomization unit was individual, the envelope randomization tool was sealed, the random sequence was constructed by coin tossing method. The random allocation concealment was done at the beginning of the study. Lady
Atefeh Hashemabadi created a random sequence with the mentioned method and examined the patients in terms of inclusion and exclusion criteria.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
Unit 223 , Narges Block 19,Shams Al-Shams Complex, Sepah Square, Tehran
City
Esfahan
Province
Isfehan
Postal code
8166173414
Approval date
2022-04-11, 1401/01/22
Ethics committee reference number
IR.MUI.MED.REC.1401.010
Health conditions studied
1
Description of health condition studied
Coronary artery heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Interleukin6
Timepoint
Measurement of interleukin 6 twelve hours after coronary heart surgery
Method of measurement
test
Secondary outcomes
1
Description
Postoperative drainage rate of coronary artery bypass graft surgery
Timepoint
48 hours after coronary aetery bypass graft surgery
Method of measurement
Chest bottle
2
Description
Rate of blood products received after coronary artery bypass graft surgery
Timepoint
48 hours after coronary artery bypass graft surgery
Method of measurement
Check the blood sheet in the patient's file
Intervention groups
1
Description
First intervention: 20 patients receiving 50 cc of 20% albumin once in each intervention at the beginning of preparation of the pump device as a prime solution in the heart pump device for priming the oxygenator tank and the path of the tubes with a blood set as The injection is inserted into the oxygenator tank, used in coronary artery bypass graft surgery. The surgery is performed by coronary artery bypass graft using a saphenous vein; This number of interventions is done within 10 months.
Category
Rehabilitation
2
Description
Second intervention: 20 patients receiving 500 cc of Voluven serum once in each intervention at the beginning of preparation of the pump device as a prime solution in the heart pump device for priming the oxygenator tank and the path of the tubes that are injected with blood. It enters the oxygenator tank, is used in coronary artery bypass graft surgery. The surgery is performed as a coronary artery bypass graft using a saphenous vein; This number of interventions is done within 10 months.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital, Isfahan
Full name of responsible person
Atefeh Hashemabadi
Street address
Salman Farsi St. Shahid Chamran Hospital
City
Esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
ati.hashemabadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Hosseini
Street address
Shahid Chamran Hospital, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
ati.hashemabadi@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
Atefe Hashemabadi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Hospital, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
hosseiny@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atefeh Hashemabadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Unit 223 , Narges Block 19,Shams Al-Shams Complex, Sepah Square, Tehran
City
Esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 21 3601 0583
Email
ati.hashemabadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Atefeh Hashemabadi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Anesthesiology
Street address
Shahid Chamran Hospital, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8166173414
Phone
+98 31 3260 0961
Email
ati.hashemabadi@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
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the participants' personal data such as information about the main outcome (changes in the interleukin test) and other consequences such as the amount of drainage and the amount of blood products received after coronary artery bypass graft surgery can be shared.
When the data will become available and for how long
Three months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
For further studies in this field and other fields and for progress in the field of science and research, the use of study data can be used for researchers and students and university professors
What processes are involved for a request to access data/document
The applicant first requests the use of documents and data by calling the respondent (Atefeh Hashemabadi), then by sending her or his e-mail to the respondent, the data will be sent to the applicant within 48 to 72 hours.