We study the preventive effect of Atorvastatin on Contrast induced nephropathy after angiography in chronic kidney disease and diabetic patients.
In this double blinded randomized clinical trial, 250 patients candidates for angiography with diabetes mellitus or chronic kidney disease and age of 55 to 75 years were included.
Patients with previous contrast media administration during the last 10 days; Patients with chronic dialysis treatment ; recent treatment with Statin 80 mg and patients requiring emergency angiography were excluded. Patients were randomized to two groups receiving Atorvastatin (80 mg/day from 48hr before angiography) and placebo.All patients received intravenous isotonic saline and N-acetylcysteine.
Variables such as hemoglobin and serum lipid profile and left ventricle ejection fraction are measured before the experiment. Before the intervention, 24 and 48 hours after the intervention, serum creatinine and BUN measured.
Contrast induced nephropathy has been defined as an increasing serum creatinine more than 0.5mg/dl or more than 25% from the base.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120117413N9
Registration date:2014-12-15, 1393/09/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-15, 1393/09/24
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah medical science university
Expected recruitment start date
2013-01-20, 1391/11/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preventive Effect of Atorvastatin 80 mg on Contrast Induced Nephropathy after Angiography in High Risk Patients
Public title
Preventive effect of atorvastatin in contarst nephropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diabetes mellitus (FBS> 126, Random BS> 200, GTT> 200); chronic renal failure (creatinine higher than 1.5 mg/dl or GFR less than 60)
Exclusion criteria: recent treatment with statin 80 mg; patients requiring emergency angiography; contraindications to prescribe statins; Patients with previous contrast media administration during the last 10 days; Patients with chronic dialysis treatment; patients with informed refusal of consent
Age
From 55 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
250
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
Baqiyatallah medical science university ethic committee
Street address
Tehran
City
Tehran
Postal code
Approval date
2012-12-31, 1391/10/11
Ethics committee reference number
6821
Health conditions studied
1
Description of health condition studied
Contrast induced nephropathy
ICD-10 code
N14
ICD-10 code description
Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions
Primary outcomes
1
Description
BUN
Timepoint
before-24 hr and 48 hr after intervention
Method of measurement
blood sampling
2
Description
creatinine
Timepoint
before-24 hr and 48 hr after intervention
Method of measurement
blood sampling
3
Description
HB
Timepoint
befor intervention
Method of measurement
blood sampling
4
Description
LVEF
Timepoint
befor intervention
Method of measurement
echocardiography
5
Description
lipid profile
Timepoint
befor intervention
Method of measurement
blood sampling
6
Description
CIN
Timepoint
24 hr and 48 hr after intervention
Method of measurement
an increasing serum creatinine more than 0.5mg/dl or more than 25% from the base
Secondary outcomes
empty
Intervention groups
1
Description
For the case group from 48 hours before performing angiography Atorvastatin 80 mg/day and for the control group placebo was prescribed. Then all of case and control groups recieved isotonic saline and N-acetylcysteine.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah hospital
Full name of responsible person
Hesam sadat Hashemi
Street address
Baqiyatallah hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Baqiyatallah university of medical science
Full name of responsible person
Gholam Hosein Alishiri
Street address
Tehran, molla sadra avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah university of medical science
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
Baqiyatallah university of medical science
Full name of responsible person
Hesam sadat Hashemi
Position
Medical student
Other areas of specialty/work
Street address
Baqiyatallah university
City
Tehran
Postal code
Phone
+98 21 7710 4021
Fax
Email
seyyedhesam.hashemi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah university
Full name of responsible person
Arezoo Khosravi
Position
assistant professor
Other areas of specialty/work
Street address
Tehran, Baqiyatallah hospital
City
Tehran
Postal code
Phone
00
Fax
Email
arekhosravi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah university
Full name of responsible person
Hamidreza Karimi sari
Position
Medical student
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)