The purpose of this study was to evaluate the effectiveness of N-acetylcysteine (N-Acetyl cysteine) on hsCRP levels in patients treated with peritoneal dialysis. All adult patients over18 years old with chronic renal failure admitted to hospital at least 6 months ago treated with peritoneal dialysis included in this study. Patients aged under18 years old, patients with history of chronic diseases such as rheumatoid arthritis and lupus, chronic inflammation, infection, hepatitis B and C in the last 3 months, exit site infections were excluded. Demographic data (age, gender), history of diabetes, duration of ESRD and dialysis was recorded. 50 patients received pharmacological intervention. Based on the amount of CRP, patients were divided into 2 groups: less than 5 mg/dl, and 5 to 50 mg/dl. Blood samples were taken to measure hsCRP. Then patients received effervescent tablets acetylcysteine (NAC) two times a day orally for 8 weeks. After re-treatment blood samples for measurement of hsCRP were taken.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014063017380N2
Registration date:2014-07-12, 1393/04/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-12, 1393/04/21
Registrant information
Name
Farzane Najafi
Name of organization / entity
Shahid Sadughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 4000
Email address
drfnajafi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
vice_chancellor of Shahid Sadoughi univercity of medical sciences
Expected recruitment start date
2013-02-26, 1391/12/08
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of N-Acetyl cysteine on hsCRP level in patients with Peritoneal Dialysis
Public title
effect of N-Acetyl cysteine on hsCRP level in patients with Peritoneal Dialysis
Purpose
Treatment
Inclusion/Exclusion criteria
including criteria: all patients with Chronic Kidney Disease over 18 years old under Peritoneal Dialysis
excluding criteria: patients under18 years old؛ history of Systemic Lupus Erythematosus, Rheumatoid Arthritis, Hepatitis c and B and CRP over 50mg/dl
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoughi univercity of medical sciences
Street address
bahonar square,yazd
City
Yazd
Postal code
Approval date
2013-02-26, 1391/12/08
Ethics committee reference number
د_291
Health conditions studied
1
Description of health condition studied
Chronic Kidney Disease
ICD-10 code
N18.1
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
high-sensitivity c reactive protein
Timepoint
before and after intervention
Method of measurement
by complete blood count test
Secondary outcomes
empty
Intervention groups
1
Description
effervescent tablets acetylcysteine (NAC) two times a day orally for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Dr Farzane Najafi
Street address
Shahid Sadoughi hospital
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice_chancellor of Shahid Sadoughi Univercity of Medical sciences
Full name of responsible person
Dr Hassan Mozafari
Street address
Bahonar square, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice_chancellor of Shahid Sadoughi Univercity 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
Shahid Sadoughi Univercity of Medical Sciences
Full name of responsible person
Dr Farzane Najafi
Position
Assistante profesor, Department of Internal Medicine
Other areas of specialty/work
Street address
Yazd
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
drfnajafi@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoughi Univercity of Medical Sciences
Full name of responsible person
Dr Farzane Najafi
Position
Assistante profesor, Depatment of Internal Medicine
Other areas of specialty/work
Street address
Yazd, Shahid Sadoughi hospital
City
Yazd
Postal code
Phone
+98 35 1822 4000
Fax
Email
drfnajafi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoughi Univercity of Medical Sciences
Full name of responsible person
Dr Farzane Najafi
Position
Assistante profesor, Department of Internal Medicine
Other areas of specialty/work
Street address
Shahid Sadoughi hospital
City
Yazd
Postal code
Phone
00
Fax
Email
drfnajafi@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)