Standard vs double dose of N-acetylcysteine to prevent contrast indused nephropathy in admitted patients in the angiography department with Glomerular Filtration Rate˂60 ml/min, in Kowsar hospital of Semnan
Objective: the effect of standard dose and twice the standard dose of N-acetylcysteine in prevention of contrast medium reception-induced nephropathy.
The study population: the patients with GFR ≤ 60 ml/minute from from baseline of study to one year after that be candidates for coronary angiography in angiography department of Semnan Kowsar hospital.
Inclusion criteria: aged 18 and older; glomerular filtration rate less than 60 ml.
Exclusion criteria: pregnant women; lactating mother; dialysis patients; blood pressure; baseline serum creatinine level greater than 7 mg/dL; severe valvular heart disease; autoimmune disorders; acute or chronic diseases; get contrast media in 10 days ago.
Sample size, intervention, intervention time, outcome of study: sample size of this study is 154 persons in 2 group of 77 peoples as intervention 1 and 2.
The intervention group 1: oral N-acetylcysteine with standard dose + 0/9% saline infusion.
The intervention group 2: oral N-acetylcysteine with twice the standard dose + 0/9% saline infusion.
Measurement of serum creatinine levels will be performed before experiment and 24, 48 and 72 hours after receiving contrast medium in Semnan Kowsar hospital. Hemoglobin and Hematocrit, fasting blood sugar and also ejection fraction from the medical records of individuals is extracted and notes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052925732N16
Registration date:2017-06-07, 1396/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-07, 1396/03/17
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2016-07-13, 1395/04/23
Expected recruitment end date
2017-07-13, 1396/04/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Standard vs double dose of N-acetylcysteine to prevent contrast indused nephropathy in admitted patients in the angiography department with Glomerular Filtration Rate˂60 ml/min, in Kowsar hospital of Semnan
Public title
Standard vs double dose of N-acetylcysteine to prevent contrast indused nephropathy in admitted patients in the angiography department with Glomerular Filtration Rate˂60 ml/min, in Kowsar hospital of Semnan
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: aged 18 and older; glomerular filtration rate less than 60 ml.
Exclusion criteria: pregnant women; lactating mother; dialysis patients; blood pressure; baseline serum creatinine level greater than 7 mg/dL; severe valvular heart disease; autoimmune disorders; acute or chronic diseases; get contrast media in 10 days ago; sensitivity to contrast media or N-acetylcysteine; oliguria (the urine volume less than 400 cc in 24 hours); acute heart failure with preserved ejection fraction <35%; receive supplements of vitamin C in the past week.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
154
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences, Deputy of research and technology, Ethics Committee
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Postal code
3514799442
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
IR.SEMUMS.REC.1395.78
Health conditions studied
1
Description of health condition studied
nephropathy
ICD-10 code
N08.3
ICD-10 code description
Diabetic nephropathy
Primary outcomes
1
Description
Serum creatinine levels
Timepoint
Before the intervention, 24, 48 and 72 hours after the intervention.
Method of measurement
Laboratory
2
Description
BUN levels
Timepoint
Before the intervention, 24, 48 and 72 hours after the intervention.
Method of measurement
Laboratory
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group 1: oral N-acetylcysteine with standard dose + 0/9% saline infusion: Received oral N-acetylcysteine, 600 mg daily, twice a day for two days (the day before receiving the contrast media + on day receiving the contrast agent) + receiving 0/9% saline infusion for 100 ml per hour, from 6 hours before receiving the contrast media and 12 hours later.
Category
Treatment - Drugs
2
Description
The intervention group 2: oral N-acetylcysteine with twice the standard dose + 0/9% saline infusion: Received oral N-acetylcysteine, 1200 mg daily, twice a day for two days (the day before receiving the contrast media + on day receiving the contrast agent) + receiving 0/9% saline infusion for 100 ml per hour, from 6 hours before receiving the contrast media and 12 hours later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Maryam Tavallaei
Street address
Kosar Hospital, Street Amin, Semnan
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences, Vice Chancellor for Research and Technology
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Sciences, Deputy of Research and Technology, Basij Blvd, Semnan
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences, Vice Chancellor for Research and Technology
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
Semnan University of Medical Sciences
Full name of responsible person
Dr Maryam Tavallaei
Position
Internal Medicine
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Maryam Tavallaei
Position
Internal Medicine
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Maryam Tavallaei
Position
Internal Medicine
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Blvd Basij, Semnan
City
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Fax
+98 23 3344 8999
Email
are20935@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)