1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
06 Nov 2022
effect of N-Acetyl cysteine on hsCRP level in patients with Peritoneal Dialysis
Protocol summary
Summary
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
2 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 291_د
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
3 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
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) empty
Study Protocol empty
Statistical Analysis Plan empty
Informed Consent Form empty
Clinical Study Report empty
Analytic Code empty Data Dictionary
empty
