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The effect of Rosuvastatin on the incidence of contrast nephropathy in patients with chronic renal failure receiving contrast

Protocol summary

Study aim
effect of Rosuvastatin in preventing decresed renal function in patients with chronic renal disease
Design
this is a clinical trial, randomized, blinded with a parallel group designed 350 chronic renal disease patients enrolled between February 2018 and March 2019 who are receive contrast media for CT scan.
Settings and conduct
patients who are refer for CT scan with contrast media to Alzahra hospital and have chronic kidney disease divide to 2 group with using random numbers. in intervention group, patients receive Rosuvastatin tablet 10 mg, 2 tablet one day before CT scan, 1 tablet just day of CT scan and 1 tablet one day after CT scan. in placebo group, placebo tablet withe the same shape and manner like intervention group are giving.
Participants/Inclusion and exclusion criteria
Patients who have not history of statin use during 3 months ago, eGFR between 30-60 cc/min/1.73m2, who are not pregnant, not receiving contrast media during 10 days ago and not using Metformin includ in the study and if they die during 72 hours after using contrast media, acute coronary syndrome, have allergy to contrast media and end stage renal disease exclude from the study
Intervention groups
in intervention group, patients receive Rosuvostatin tablet 10 mg, manufactured by Abidi pharmaceutic, 2 tablet one day before CT scan , 1 tablet in the day of CT scan and 1 tablet 1 day after CT scan. in placebo group, Placebo tablet manufactured by Abidi pharmaceutic, with the same shape to intervention group and the same manner give them
Main outcome variables
creatinin measurement at baseline and after 48 hours of receiving contrast media

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090905002417N21
Registration date: 2019-07-07, 1398/04/16
Registration timing: retrospective

Last update: 2019-07-07, 1398/04/16
Update count: 0
Registration date
2019-07-07, 1398/04/16
Registrant information
Name
Firouzeh Moeinzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
moinzade@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rosuvastatin on the incidence of contrast nephropathy in patients with chronic renal failure receiving contrast
Public title
Effect of Rosuvastatin in contrast induced nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
absence of Statin use during past 3 months eGFR between 30 - 60 cc/min/1.73m2 not pregnant absence use of contrast during past 10 days absence use of Metformin
Exclusion criteria:
Acute coronary syndrome history of allergy to contrast media death during 72 hours after receiving contrast media end stage renal disease
Age
From 18 years old to 90 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 350
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization with random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
patients who are arrived in the study, the trained nurse who is directing patients into the study, investigator, data analyser
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR.mui.rec.1396.3.986

Health conditions studied

1

Description of health condition studied
Effect of Rosuvostatin in contrast induced nephropathy in chronic kidney disease
ICD-10 code
N18.3
ICD-10 code description
chronic kidney disease

Primary outcomes

1

Description
serum creatinin level
Timepoint
48 hours after contrast media use
Method of measurement
autoanalyser

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 175 patients is entered in study that they have chronic kidney disease and their eGFR are 30-60mg/dL. one day before contrast administration, they eat 2 tablet Rosuvastatin, Abidi pharmaceutic, IRAN. in the day of contrast administration and one day after that, they receive one tablet the same as before. 48 hours after contrast administration they undergo laboratory examination.
Category
Treatment - Drugs

2

Description
Control group: 175 patients is entered in study that they have chronic kidney disease and their eGFR are 30-60mg/dL. one day before contrast administration, they eat 2 tablet (placebo) Rosuvastatin, Abidi pharmaceutic, IRAN. in the day of contrast administration and one day after that, they receive one tablet the same as before. 48 hours after contrast administration they undergo laboratory examination.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Marziye Rezaei
Street address
Sofe Ave. Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2267
Email
raha_m2@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Isfahan University of Medical Science, Hezarjarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
ّّFirouzeh Moeinzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Sofe Ave. Isfahan
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2267
Email
fimoinzad@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Firouzeh Moeinzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Sofe Avenue Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2267
Email
fimoinzad@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Firouzeh Moeinzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Sofe Avenue, Isfahan
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2267
Email
f_moinzade@med.mui.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
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
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
the shareable data contain points that will be published in the article.
When the data will become available and for how long
Starting 1 year after publication
To whom data/document is available
Available for academic investigators and industrial persons
Under which criteria data/document could be used
for more information contact us with email.
From where data/document is obtainable
contact with email
What processes are involved for a request to access data/document
maximum 1 year after sending your email we response you
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