The effect of curcumin in the prevention of contrast induced nephropathy in patients with moderate kidney failure following coronary angioplasty or angiography
Contrast nephropathy is the most common cause of iatrogenic acute kidney injury. This problem particularly in CKD patients is more common. In various studies, the positive effect of antioxidants in preventing of it is suggested. Therefore, we decided to study the antioxidant effect of curcumin in the prevention of contrast nephropathy in moderate chronic kidney disease patients.
All patients with stable angina and unstable or non-ST elevated MI in the of Ghaem and Imam Reza hospital who are candidates for elective and/or emergency coronary angiography or angioplasty enrolled in study, if creatinine more than 1.2 or GFR between 30 to 60 ml / min are based on prior lab tests. It is done as a double blind study for both patients and physicians. 30 patients will be randomly allocated to receive capsule Curcumin 500 mg three times daily from 2 days before angiography until 3 days after it and 30 patients in control group will receive placebo to the same extent. In both groups, from 12 hours before angiography normal saline solution infuse at a rate of 1ml/Kg/hr and it will continue to 12 hours after that. Serum creatinine will be reevaluate in second and third days after angiography. Urinary NGAL will be assessed in the next day of angiography.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706261256N1
Registration date:2017-10-24, 1396/08/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-24, 1396/08/02
Registrant information
Name
Maryam Hami
Name of organization / entity
Health Organization
Country
Iran (Islamic Republic of)
Phone
+98 51 1765 9556
Email address
hamim@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-10-11, 1395/07/20
Expected recruitment end date
2017-05-01, 1396/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of curcumin in the prevention of contrast induced nephropathy in patients with moderate kidney failure following coronary angioplasty or angiography
Public title
The effect of curcumin in the prevention of kidney failure following heart angiography
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients undergoing elective coronary angiography who are older than 18 years and are suffering from chronic kidney failure.
Exclusion criteria: patients on dialysis, acute renal failure before angiography, cardiogenic shock, heart failure, use of medications such as N-acetyl cysteine, vitamin C, use of intravenous contrast to other causes, mannitol, diuretics, theophylline, warfarin and dopamine in the past two weeks.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University Of Medical sciences ethics Committee
Street address
Vice President of Research, Ghoreshi building, Daneshgah st.
City
Mashhad
Postal code
Approval date
2016-08-17, 1395/05/27
Ethics committee reference number
IR.MUMS.sm.REC.1395.220
Health conditions studied
1
Description of health condition studied
Acute kidney injury
ICD-10 code
N17, N18,
ICD-10 code description
Renal Failure
Primary outcomes
1
Description
serum creatinine
Timepoint
0,1,3 days- 1th day
Method of measurement
mg/dl
2
Description
urinary NGAL
Timepoint
First day
Method of measurement
ng/ml
Secondary outcomes
1
Description
nausea
Timepoint
daily
Method of measurement
history &physical exam
2
Description
diarrhea
Timepoint
daily
Method of measurement
history &physical exam
Intervention groups
1
Description
Control group receive placebo capsule 500 mg three times daily from 2 days before angiography until 3 days after it.
Category
Treatment - Drugs
2
Description
Intervention group receive Curcumin capsule 500 mg three times daily from 2 days before angiography until 3 days after it.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Street address
City
Mashhad
2
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor Of Research, Mashad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice President of Research- Ghoreshi building- Daneshgah st.
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor Of Research, Mashad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Vice Chancellor Of Research, Mashad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Position
Vice Chancellor Of Research
Other areas of specialty/work
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Postal code
Phone
+98 51 3841 1538
Fax
Email
tafaghodim@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Vice Chancellor Of Research, Mashad University of Medical Sciences
Full name of responsible person
Maryam Hami
Position
Associated Professor Of Nephrology
Other areas of specialty/work
Street address
Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 3801 2837
Fax
Email
hamim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Amir Bigdeli
Position
Fellowship of Nephrology
Other areas of specialty/work
Street address
Ghaem Hospital, Imam Reza Hospital
City
Mashhad
Postal code
9178511111
Phone
+98 51 3847 7416
Fax
+98 51 3229 1960
Email
bigdelia941@mums.ac.ir
Web page address
http://rsc-ktc.mums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)