Evaluating the effect of ubiquinone (CoQ10) on the prevention of postoperative Acute Kidney Injury (AKI) following Coronary Artery Bypass Grafting surgery (CABG)
Evaluation of ubiquinone effects on the prevention of Acute Kidney Injury after Coronary Artery Bypass Graft surgery
Design
In this study, 50 patients who are candidates for Coronary Artery Bypass Graft surgery and referred to Masih Daneshvari Hospital in Tehran are enrolled in the study. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
Place of study: Masih Daneshvari Hospital
How to do the study: 50 patients who are candidates for Coronary Artery Bypass Graft surgery are randomly divided into two intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who undergo Coronary Artery Bypass Grafting at Masih Daneshvari Hospital are randomly enrolled in the study; there are no restrictions on age and gender for entry.
Exclusion criteria: History of hypersensitivity reaction to ubiquinone; Chronic liver failure (Stage II & III); Chronic Kidney Disease (Stage IV & V) or patients with Glomerular Filtration Rate of lower than 30 ml/min; Patient with INR of more than 2.5; Patients who receive anti-inflammatory agents at least two weeks before admission; Patients who undergo emergency CABG.
Intervention groups
In the drug group, patients will receive 600 mg of ubiquinone (300 mg every 12 hours) for 2 days before surgery. The control group does not receive the drug.
Main outcome variables
Incidence of Acute Kidney Injury; Increasing of NGAL biomarker
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151227025726N16
Registration date:2020-05-28, 1399/03/08
Registration timing:retrospective
Last update:2020-05-28, 1399/03/08
Update count:0
Registration date
2020-05-28, 1399/03/08
Registrant information
Name
Farzaneh Dastan
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 270 5933
Email address
f_dastan@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Faculty of Pharmacy, Shahid Baheshti University of Medical Sciences
Expected recruitment start date
2016-06-19, 1395/03/30
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
2016-06-19, 1395/03/30
Actual recruitment end date
2017-06-20, 1396/03/30
Trial completion date
2017-07-21, 1396/04/30
Scientific title
Evaluating the effect of ubiquinone (CoQ10) on the prevention of postoperative Acute Kidney Injury (AKI) following Coronary Artery Bypass Grafting surgery (CABG)
Public title
Evaluating the effect of ubiquinone (CoQ10) on the prevention of Acute Renal Injury following open heart surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patients who are candidates for Coronary Artery Bypass Graft surgery in Masih Daneshvari Hospital
Exclusion criteria:
History of hypersensitivity reaction to ubiquinone
Chronic liver failure (Stage II & III)
Chronic kidney disease (Stage IV & V) or patients with Glomerular Filtration Rate of lower than 30 ml/min
Patient with INR of more than 2.5
Patients who receive anti-inflammatory agents at least two weeks before admission
Patients who undergo emergency CABG.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
3
Plasma sample
Actual sample size reached:
50
More than 1 sample in each individual
Actual sample size in each individual:
3
Plasma sample
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method using table of random numbers is applied to the study population. Unit of randomization is individual. Even and odd numbers are chosen for the case and the control group, respectively. Numbered drug containers are applied for allocation concealment.
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 School of Pharmacy, Nursing, and Midwifery; Shahid Beheshti University of Medica
Street address
No. 2660, Vali-e Asr St., Niyayesh Junction, Tehran
City
Tehran
Province
Tehran
Postal code
141556153
Approval date
2016-03-01, 1394/12/11
Ethics committee reference number
IR.SBMU.PHNM.1394.311
Health conditions studied
1
Description of health condition studied
Acute Kidney Injury
ICD-10 code
N99.0
ICD-10 code description
Postprocedural (acute) (chronic) kidney failure
Primary outcomes
1
Description
Acute Kidney Injury
Timepoint
before surgery and 6 & 24 hours after surgery
Method of measurement
Evaluation of NGAL kits
Secondary outcomes
1
Description
Checking of inflammatory biomarkers
Timepoint
before surgery and 24 hours after surgery
Method of measurement
Evalution of CRP kit
Intervention groups
1
Description
Intervention group: administration of ubiquinone oral tablets, 300 mg, 2 times a day (every 12 hours), for 2 days (48 hours before surgery)
Category
Prevention
2
Description
Control Group: will not receive the drug .
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Farzaneh Dastan
Street address
Masih Daneshvari Hospital, Daar-Abad, Shahid Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Email
fzh.dastan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 23871
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Masih Daneshvari Hospital
Full name of responsible person
Alireza Jahangirifard
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Masih Daneshvari Hospital, Daar-Abad, Shahid Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Fax
Email
alirezajahangiri@sbmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Farzaneh Dastan
Position
Assisstant Professor, Clinical Pharmacy Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Valieasr St., Intersection of Niyayesh Highway, Shahid Beheshti University of Medical Sciences, Faculty of Pharmacy
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Fax
Email
fzh.dastan@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Masih Daneshvari Hospital
Full name of responsible person
Raha Eskandari
Position
Pharm.D
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Masih Daneshvari Hospital, Daar-Abad, Shahid Bahonar St. (Niavaran)
City
Tehran
Province
Tehran
Postal code
1956944413
Phone
+98 21 2712 3000
Fax
Email
eskandari_raha@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
All potential data can be shared after blinding.
When the data will become available and for how long
Six months after results publishing
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
For research purposes and meta-analysis studies
From where data/document is obtainable
Dr. Farzaneh Dastan, Masih Daneshvari Hospital, Daar-Abad, Niavaran
What processes are involved for a request to access data/document