The Effect of L-Carnitine on the Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary Angiography in Heshmat Hospital in 2017:a Randomized Clinical Trial
Determination of the effect of L-carnitine on the prevention of contrast-induced nephropathy in patients undergoing angiography
Design
The two study groups will include the group receiving the drug, L-carnitine and the non-receiving drug group. Patients will be evaluated after the procedure for CIN occurrence. The patient's GFR will be calculated using the MDRD equation according to SrCr.In the study of wenhua and colleagues, The incidence of contrast-induced nephropathy was reported in the group receiving L-carnitine and control group of 6.9% and 19.2%, respectively. Accordingly, with the assumption of α = 0.05 and ß = 0.20, 114 samples obtaine the sample size from each group . Considering 20% of the missing data, the number of required samples in each group will rise to 143 Samples .
Settings and conduct
This study will be conducted in the form of Prospective Randomized Controlled Trial in D.R Heshmat Educational Medical Research Center in Rasht.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All patients who undergo elective angiography and PCI after approval plan in 2017 will be located at D.R Heshmat Educational Medical Research Center;
Exclusion criteria: ST elevation MI in Pregnancy; History of CABG within 6 months ago; History of PCI within 6 months ago; Cardiogenic shock; Simultaneous use of nephrotoxic drugs ; exposuring to contrast material (from 2 days before 2 days later); Renal transplantation History; Thyroid and Corticosteroids disorders; LVEF<35%; Patients who have not received full doses of medication after entering the study due to digestive complications or incompleteness of the drug will be excluded from the study.
Intervention groups
L-Carnitine drug Receiving Group
control group
Main outcome variables
It reduces the complications of angiography and morbidity.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180921041079N1
Registration date:2019-03-19, 1397/12/28
Registration timing:retrospective
Last update:2019-03-19, 1397/12/28
Update count:0
Registration date
2019-03-19, 1397/12/28
Registrant information
Name
Abdul Hassan Sancholy tazh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3366 3070
Email address
e.ramezanzade@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of L-Carnitine on the Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary Angiography in Heshmat Hospital in 2017:a Randomized Clinical Trial
Public title
The Effect of L-Carnitine on the Prevention of Contrast Induced Nephropathy in Patients Undergoing Coronary Angiography in Heshmat Hospital in 2017
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who Undergo Elective Angiography and PCI After Approval of the Plan in 1396 Will be Located at Rasht Medical Center.
Patient Satisfaction: The Willingness to Participate in the Study and Sampling
Exclusion criteria:
ST elevation MI
Pregnancy
History of CABG in the last 6 months
History of PCI in the last 6 months
Cardiogenic shock
Simultaneous use of nephrotoxic drugs
Recent exposure to contrast material (from 2 days before 2 days later)
Renal transplantation biography
Thyroid disorders
Corticosteroids
LVEF<35%
Patients who have not received full doses of medication after entering the study due to Digestive complications or incompleteness of the drug will be excluded from the study.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
143
Randomization (investigator's opinion)
Not randomized
Randomization description
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 guilan University of Medical Sciences
Street address
Dr. Heshmat Rasht Hospital -Masala Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
413955588
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.GUMS.REC.1397.107
Health conditions studied
1
Description of health condition studied
Cardiac patients are candidates for angiography
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Contrast Nephropathy
Timepoint
L carnitine is given 24 hours before coronary angiography and then every 8 hours
Intervention group: From the 24 hours before the coronary artery bypass graft surgery, 3000 milligrams of L-carnitine solution (1 g per 10 ml) will be given at intervals of 8 hours. After the procedure, within 24 hours, the dietary intake of L-carnitine will be 3000 mg (1000 mg three times a day). Since oral intake of carnitine is saturated in 2 grams, the doses are given in divided doses, also routine care (hydration with N.S. serum)is done.
Category
Prevention
2
Description
Control group: The control group does not receive L-carnitine and only routine care is provided.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hashmat hospital
Full name of responsible person
Abdulhassan SanchulyTaze
Street address
Maslieh Square., Bayani Ave, Rasht Town; Dr. Heshmat Hospital
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
E.Ramezanzade@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
University of Technology Research and Technology, Old Building School of Health, Faced to the 17th Shahrivar Hospital, Shahid Siadati St, Namjoo Ave, Rashtو
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5821
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Abdulhassan schnuculy taze
Position
Cardiovascular Assistant
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Dr. Heshmat Rasht Hospital, Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
E.Ramezanzade@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Abdulhassan schnuculy taze
Position
Cardiovascular Assistant
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Dr. Heshmat Rasht Hospital,Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
E.Ramezanzade@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Abdulhassan schnuculy taze
Position
Cardiovascular Assistant
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Dr. Heshmat Rasht Hospital, Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
E.Ramezanzade@gums.ac.ir
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
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Intervention group receiving L-Carnitine
When the data will become available and for how long
24 hours before coronary angiography, then every 8 hours
To whom data/document is available
For researchers working in academic and scientific institutions
Under which criteria data/document could be used
To prevent nephropathy
From where data/document is obtainable
Heshmat Rasht Hospital
What processes are involved for a request to access data/document