1.Objectives:The main purpose of this study is to determine effect of N-Acetyl cystein on residual renal function in chronic hemodialysis patients treated with low flux synthetic dialysis membrane.
2. Design:This study is a randomized, triple-blind, placebo control uni-central study.The study includes 106 patients with ESRD and undergoing chronic hemodialysis.
3. Setting and conduct: patients were divided into two 53-member groups with meshing randomization method. NAC pill was fed to one group and placebo to another one.
4. Inclusion criteria: patients should be treated with hemodialysis for at least 1 year, having more than 100 ml urine in 24 hr, and should be under treated with hemodialysis 3-times a week.
Exclusion criteria: patients who have been currently treated with diuretics or antioxidants such as NAC, vitamin C and vitamin E.
5.Intervention: In this study 53 patients received NAC and 53 ones received placebo.
6.Main outcome measurements: midweek interdialytic urine collection for the measurement of urine output, calculation of residual renal Kt/V and glomerular filtration rate(GFR) (before and after the intervention).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122325675N1
Registration date:2016-01-30, 1394/11/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-30, 1394/11/10
Registrant information
Name
Fahime Abaforush
Name of organization / entity
Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61335524122
Email address
abaforush.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Ahvaz University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-06-21, 1395/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of N-Acetyl cystein on residual renal function in chronic hemodialysis patients treated with low flux synthetic dialysis membrane
Public title
Effect of N_ acetyl cyctein on hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients were treated with hemodialysis for at least 1 year, having more than 100 ml urine in 24 hr, treated with hemodialysis 3-times a week.
Exclusion criteria: patients were currently treated with diuretics or antioxidants such as NAC, vitamin C and vitamin E.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Meshing randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Golestan Blv
City
Ahvaz
Postal code
61357_15794
Approval date
2015-12-05, 1394/09/14
Ethics committee reference number
IR.AJUMS.REC.1394.471
Health conditions studied
1
Description of health condition studied
chronic hemodialysis patients
ICD-10 code
XIV
ICD-10 code description
N17_N19
Primary outcomes
1
Description
residual renal function
Timepoint
before intervention and one month after intervention
Method of measurement
midweek inter dialytic urine collection for measurement of urine output and calculation of residual renal kt/v and GFR