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Efficacy of short-term high-dose lovastatin in prevention of contrast-induced acute kidney injury in patients receiving intravenous contrast drugs

Protocol summary

Summary
This study is designed to evaluate the effect of lovastatin on the prevention of contrast-induced nephropathy in receiving intravenous contrast patients. Single center randomized, double-blind study will be conducted on 122 patients. After consent obtaining, patients information’s such as age, sex, history of chronic and acute renal disease, underlying disease, diagnostic intervention, drug history, previous use of statins and known history of statins hypersensitivity will be recorded. The subjects randomly will be divided into drug and placebo groups. In the lovastatin group, 60 milligrams lovastatin will be administered 24 hours before diagnostic procedures, the day of the procedure and 24 hours after contrast injection. In the placebo group, placebo will be administered 24 hours before, the day of the procedure and 24 hours after contrast injection. In the first time and 48 hours after contrast injection to measure serum creatinine, blood samples will be taken. Increased serum creatinine greater than 0.5 mg per deciliter or an increased more than 25 percent of the base is considered as contrast-induced acute kidney injury.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017041033359N1
Registration date: 2017-05-15, 1396/02/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-15, 1396/02/25
Registrant information
Name
Mohammad saad forghani
Name of organization / entity
Kurdistan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 875 2138
Email address
m.s.forghani@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of short-term high-dose lovastatin in prevention of contrast-induced acute kidney injury in patients receiving intravenous contrast drugs
Public title
lovastatin effect in preventing of contrast induced acute kidney injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients that need intravenous contrast administration. Exclusion criteria: Acute kidney injury; acute coronary syndrome and acute myocardial infarction; statin sensitivity; patients Dissatisfaction
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 122
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
kurdistan university of medical scieces, Pasdran St, sanandaj,Iran, Islamic Republic Of
City
Sanandaj
Postal code
6617713446
Approval date
2015-07-23, 1394/05/01
Ethics committee reference number
MUK.REC. 1394/143

Health conditions studied

1

Description of health condition studied
Contrast induced acute kidney injury
ICD-10 code
N17.8
ICD-10 code description
Other acute renal failure

Primary outcomes

1

Description
Acute kidney injury
Timepoint
Basline and 4h hours after diagnostic intervention
Method of measurement
Serum creatinine and MDRD e GFR

2

Description
Acute kidney injury
Timepoint
48 h after intervention
Method of measurement
Serum creatinine and MDRD e GFR

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, 60 milligrams of lovastatin administered on the day before the procedure, the day of the procedure, and the day after the procedure.
Category
Treatment - Drugs

2

Description
The control group received placebo similar to lovastatin tabletes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tohid hospital
Full name of responsible person
Khaled Fathizadeh
Street address
Pasdaran St.
City
Sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of kurdistan University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Kurdistan University of Medical Sciences, Pasdaran St, Iran, Islamic Republic Of
City
Sanandaj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Khled fathizadeh
Position
Internal Medicine resident
Other areas of specialty/work
Street address
University of Medical Sciences, Pasdaran St, Kurdistan, Iran, Islamic Republic Of
City
Sanandaj
Postal code
Phone
+98 87 3328 6117
Fax
Email
khaledfathizadeh54@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Mohammad Saad Forghani
Position
Nephrologist
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, Pasdaran St, Sanandaj, IranIslamic Republic Of
City
Sanandaj
Postal code
66177-13446
Phone
+98 87 3328 6116
Fax
Email
forghani1979@gmail.com ,m.s.forghani@muk.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Khaled Fathizadeh
Position
Internal medicine resident
Other areas of specialty/work
Street address
Pasdaran St.Kurdistan University of Medical Sciences
City
Sanandaj
Postal code
Phone
00
Fax
Email
khaledfathizadeh54@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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