Contrast induced nephropathy(CIN) is the third cause of acute kidney injury(AKI) in hospitalized patients. It is associated with high rate of morbidity and mortality. Prevention is the only modality for managing this disorder and although many studies have been performed in this regard, there are many controversies about the preventing measures. One of the most controversies in preventing of this disorder is about the role of N-Acetyle cystein. In our study 732 adult patients with chronic kidney disease whom undergo coronary angiography/angioplasty will be randomly allocated into 4 groups. Two of them recieved N-acetyl cystein orally or intravenously respectively and two other groups will recieve placebo either orally or intravenously. The study is anticipated to complete in one year. The contrast nephropathy is defined as 25% increase in serum creatinine frome the base.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205305113N3
Registration date:2012-06-24, 1391/04/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-24, 1391/04/04
Registrant information
Name
Seyyed Mohammad Reza Khatami
Name of organization / entity
Nephrology Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2659
Email address
khatamis@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
The research grant budget of nephrology research center of Tehran University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of N-Acetyle Systeine in preventing contrast induced nephropathy in patients with different stages of chronic kidney diseases
Public title
N- Acetyle Systeine and Contrast nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age more than 18; serum creatinine more than 1.5 mg/ dl ; not having AKI; not receiving nephrotoxine since 1 week before entering the study; signing the consent.
Exclusion criteria: the patients who undergo surgery in less than 1 week of contrast exposure; the patients who are in need for a nephrotoxine in less than five days after contrast exposure; the patients who need repeated contrast administration in less than five days of first exposure
Age
From 18 years old to 99 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
549
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
Tehran University of Medical Sciences
Street address
Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2012-05-21, 1391/03/01
Ethics committee reference number
12345
Health conditions studied
1
Description of health condition studied
Nephropathy due to contrast agents
ICD-10 code
N99.0
ICD-10 code description
Postprocedural renal failure
Primary outcomes
1
Description
serum creatinine
Timepoint
The second day and five days after contrast exposure
Method of measurement
Serum creatinine in plasma
Secondary outcomes
1
Description
Hypersensitivity to contrast
Timepoint
Immediately after exposure to contrast
Method of measurement
Physical conditions
Intervention groups
1
Description
Intervention1: ampule N-acetyl cystein 1200 mg intravenously half an hour before contrast administration
Category
Prevention
2
Description
Intervention 2: Tablet N-acetyl cystein 600 mg bid, starting from the day before contrast administration and continued until the day after that.
Category
Prevention
3
Description
Control1: intravenous saline 3 cc half an hour before contrast administration
Category
Placebo
4
Description
Control2: Placebo tablet bid starting the day before contrast administration and continue until the day after that.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Heart Center
Full name of responsible person
Mohammad Reza Khatami
Street address
Transplany unit, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nephrology Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mahboob lessan pezeshki
Street address
Imam Khomeini hospital, Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nephrology Research Center, Tehran 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
Nephrology Research Center
Full name of responsible person
Mohammad Reza Khatami
Position
Associate professor
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2659
Fax
Email
khatamis@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nephrology Research Center
Full name of responsible person
Mohammad Reza Khatami
Position
Associate professor
Other areas of specialty/work
Street address
Associate professor
City
Tehran
Postal code
Phone
+98 21 6119 2659
Fax
Email
khatamis@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nephrology Research Center
Full name of responsible person
Mohammad reza khatami
Position
Associate professor
Other areas of specialty/work
Street address
Imam khomeini hospital, keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6119 2659
Fax
Email
khatamis@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)