Evaluating the effect of Del Nido cardioplegia solution containing Vitamin C on perioperative clinical outcomes and laboratory criteria of CABG patients
Main goal:
Evaluating and study the effect of Del Nido cardioplegia solution containing Vitamin C on perioperative clinical outcomes and laboratory criteria of CABG patients
Design
Clinical trial with control group, with parallel groups, Randomized, designed for 70 patients, Block randomization with size 6 and Individual randomization unit (using https://www.sealedenvelope.com/simple-randomiser/v1/lists;CREATE A RANDOMISATION LIST)
Settings and conduct
Rajee Heart center
For gathering data in this trial consent form will be taken from suitable candidates before entering the operation room and then patients in order of acceptance in OR using described randomization(using https://www.sealedenvelope.com/simple-randomiser/v1/lists;CREATE A RANDOMISATION LIST) ; randomized into vitamin C group (35 patients) and control group (35 patients) and eventually 70 patients will participate in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Tendency to participate
2-Consent
3-Age between 30 to 70
4-LVEF more than 30%
Exclusion criteria:
1-Above normal range cardiac enzymes
2-History of sternotomy and previous cardiac surgeries
3-History of Liver, Kidney, Pulmonary diseases
4-Valve problems that requires concurrent surgery
5-Having pacemaker
6-Pregnancy
7-History of allergic reaction to Vitamin C
8-G6PD deficiency
Intervention groups
Intervention group: adding 3 gram of injectable Vitamin C ( 6 VITAMIN C DP 500MG/5ML AMP) to Del Nido cardioplegia solution (1 L Plasma-Lyte A base solution to which the following are added: Mannitol 20%, 16.3 mL Magnesium sulfate 50%, 4 mL Sodium bicarbonate 8.4%, 13 mL Potassium chloride (2 mEq/mL), 13 mL Lidocaine 1%, 13 mL)
Control group: Inject Del Nido cardioplegia solution
Main outcome variables
Troponin
CK-MB
BUN
Cr
LFT
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220716055477N1
Registration date:2022-08-15, 1401/05/24
Registration timing:prospective
Last update:2022-08-15, 1401/05/24
Update count:0
Registration date
2022-08-15, 1401/05/24
Registrant information
Name
Mohammadhadi Mozayan
Name of organization / entity
Rajaee Heart Center
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4118
Email address
hadimozayan@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-06, 1401/06/15
Expected recruitment end date
2023-03-06, 1401/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of Del Nido cardioplegia solution containing Vitamin C on perioperative clinical outcomes and laboratory criteria of CABG patients
Public title
Evaluating the effect of Del Nido cardioplegia solution containing Vitamin C on perioperative clinical outcomes and laboratory criteria of CABG patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Tendency to participate
Consent
Age between 30 to 70
LVEF more than 30%
Exclusion criteria:
Above normal range cardiac enzymes
History of sternotomy and previous cardiac surgeries
History of Liver, Kidney, Pulmonary diseases
Valve problems that requires concurrent surgery
Having pacemaker
Pregnancy
History of allergic reaction to Vitamin C
G6PD deficiency
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization with size 6 and Individual randomization unit (using https://www.sealedenvelope.com/simple-randomiser/v1/lists;CREATE A RANDOMISATION LIST) a list with 72 numbers that accidentally divided into two different groups was made. First group consider as intervention group and second group consider as control groups. For gathering data in this trial consent form will be taken from suitable candidates before entering the operation room and then patients in order of acceptance in OR (with completely interchangeable orders) based on created numbers that described earlier will be divided into vitamin C group (35 patients) and control group (35 patients) and eventually 70 patients will participate in this trial.
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 Rajaee Heart Center
Street address
Rajaee Heart Center, Next to Mellat Park, Valiasr street
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2022-07-16, 1401/04/25
Ethics committee reference number
IR.RHC.REC.1401.021
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Graft Surgery
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Troponin I is a cardiac and skeletal muscle protein family. It is a part of the troponin protein complex, where it binds to actin in thin myofilaments to hold the actin-tropomyosin complex in place. Troponin I prevents myosin from binding to actin in relaxed muscle. When calcium binds to the troponin C, it causes conformational changes which lead to dislocation of troponin I. Afterwards, tropomyosin leaves the binding site for myosin on actin leading to contraction of muscle. The letter I is given due to its inhibitory character. It is a useful marker in the laboratory diagnosis of heart attack. It occurs in different plasma concentration but the same circumstances as troponin T - either test can be performed for confirmation of cardiac muscle damage and laboratories usually offer one test or the other
Timepoint
pre-operation, upon admission to the Intensive Care Unit, and 24 hours later
Method of measurement
Using accurate laboratory kits
2
Description
Creatine kinase-MB (CK-MB) is a form of an enzyme found primarily in heart muscle cells. This test measures CK-MB in the blood.CK-MB is one of three forms (isoenzymes) of the enzyme creatine kinase (CK). These isoenzymes include :CK-MM (found in skeletal muscles and the heart)CK-MB (found mostly in the heart, but small amounts found in skeletal muscles)CK-BB (found mostly in the brain and smooth muscle, such as the intestines and uterus)CK is released from muscle cells and is detectable in the blood whenever there is muscle damage. The small amount of CK that is normally in the blood is primarily CK-MM. CK-BB almost never gets into the blood, and CK-MB will typically only be present in significant amounts when the heart is damaged. A CK test measures the total level but does not distinguish between the three isoenzymes. When there is an increased amount of CK present in the blood, the CK-MB test can be used to determine whether it is due to heart damage or is more likely to be related to skeletal muscle injury.
Timepoint
pre-operation, upon admission to the Intensive Care Unit, and 24 hours later
Method of measurement
Using accurate laboratory kits
Secondary outcomes
1
Description
Blood urea nitrogen (BUN) is a medical test that measures the amount of urea nitrogen found in blood. The liver produces urea in the urea cycle as a waste product of the digestion of protein. Normal human adult blood should contain 6 to 20 mg/dL (2.1 to 7.1 mmol/L) of urea nitrogen. Individual laboratories will have different reference ranges as the assay used can vary between laboratories. The test is used to detect renal problems.
Timepoint
pre-operation, upon admission to the Intensive Care Unit, 24 and 48 hours later
Method of measurement
Using accurate laboratory kits
2
Description
Serum creatinine (a blood measurement) is an important indicator of kidney health because it is an easily measured byproduct of muscle metabolism that is excreted unchanged by the kidneys. Creatinine itself is produced via a biological system involving creatine, phosphocreatine (also known as creatine phosphate), and adenosine triphosphate (ATP, the body's immediate energy supply).
Timepoint
pre-operation, upon admission to the Intensive Care Unit, 24 and 48 hours later
Method of measurement
Using accurate laboratory kits
3
Description
Liver function tests (LFTs or LFs), also referred to as a hepatic panel, are groups of blood tests that provide information about the state of a patient's liver. The liver transaminases aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) are useful biomarkers of liver injury in a patient with some degree of intact liver function.
Timepoint
pre-operation, upon admission to the Intensive Care Unit, 24 and 48 hours later
Method of measurement
Using accurate laboratory kits
Intervention groups
1
Description
Intervention group: adding 3 gram of injectable Vitamin C ( 6 VITAMIN C DP 500MG/5ML AMP) to Del Nido cardioplegia solution (1 L Plasma-Lyte A base solution to which the following are added: Mannitol 20%, 16.3 mL Magnesium sulfate 50%, 4 mL Sodium bicarbonate 8.4%, 13 mL Potassium chloride (2 mEq/mL), 13 mL Lidocaine 1%, 13 mL)
Category
Treatment - Drugs
2
Description
Control group: Inject Del Nido cardioplegia solution (1 L Plasma-Lyte A base solution to which the following are added: Mannitol 20%, 16.3 mL Magnesium sulfate 50%, 4 mL Sodium bicarbonate 8.4%, 13 mL Potassium chloride (2 mEq/mL), 13 mL Lidocaine 1%, 13 mL)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajee Heart center
Full name of responsible person
Mohammadhadi Mozayan
Street address
Rajaee Heart Center, Next to Mellat Park, Valiasr street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
hadimozayan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaee Heart Center
Full name of responsible person
Dr.Majid Maleki
Street address
Rajaee Heart center, Next to Mellat Park, Valiasr street
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
hadimozayan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaee Heart Center
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
Rajaee Heart Center
Full name of responsible person
Mohammadhadi Mozayan
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO. 4, left hand , 8th South Parsian Blvd, Rokabad Town, Shiraz
City
Shiraz
Province
Fars
Postal code
7149635572
Phone
+98 71 3242 4118
Fax
Email
hadimozayan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaee Heart Center
Full name of responsible person
Mohammadhadi Mozayan
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO. 4, left hand , 8th South Parsian Blvd, Rokabad
City
Shiraz
Province
Fars
Postal code
7149635572
Phone
+98 71 3242 4118
Email
hadimozayan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rajaee Heart Center
Full name of responsible person
Mohammadhadi Mozayan
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO. 4, left hand , 8th South Parsian Blvd, Rokabad Town, Shiraz
City
Shiraz
Province
Fars
Postal code
7149635572
Phone
+98 71 3242 4118
Email
hadimozayan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Evaluating the effect of Del Nido cardioplegia solution containing Vitamin C on perioperative clinical outcomes and laboratory criteria of CABG patients
When the data will become available and for how long
The access period starts 6 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
Science production and teaching methodology
From where data/document is obtainable
Dr. Farshad Jalili Shahandashti
Jalilishfarshad@gmail.com
What processes are involved for a request to access data/document