comparison of the effectiveness of adding N-acetylcysteine to current standard treatment with standard treatment alone on improving residual renal function in chronic peritoneal and hemodialysis patients
The aim of this study is to investigate the effect of N-acetyl cysteine on improvement of residual renal function in patients treated with hemodialysis and peritoneal dialysis.
In a multicenter prospective trial, those patients with hemodialysis and peritoneal dialysis in Imam Khomeini, Amir alam, Sina hospitals also Urmia and Kerman medical centers who has been under dialysis for more than 3 months and residual urine output of at least 100 mL/24 hours are included in the study. Antioxidant consumption such as vitamins E and C cause exclusion of patients. The total number of 120 patients with above-mentioned features is included in the study. The patients are randomly assessed in 4 randomized blocks method in one of control or intervention groups. The study is designed as a single blind and the patients are incognizant of the intervention.
About 60 patients in the control group receive standard treatment including antihypertensive, group B vitamins and statin or A.S.A if necessary. Moreover, about 60 patients in the intervention group as well as standard treatment receive effervescent tablets N-acetyl cysteine 1200 mg two times a day for 3 months. The amount of residual renal function before and after the medication is studied. In order to measure the amount of residual renal function, the amount of 24 hour urine and the mean of urea and creatinine clearance is calculated. Besides, the amount of KT/V is also calculated for each patient. The values will be compared before and after completion of intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014071418482N1
Registration date:2014-09-26, 1393/07/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-26, 1393/07/04
Registrant information
Name
Mahsa Abbaszadeh
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 2456
Email address
m-abbaszadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-08-17, 1393/05/26
Expected recruitment end date
2014-12-20, 1393/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of the effectiveness of adding N-acetylcysteine to current standard treatment with standard treatment alone on improving residual renal function in chronic peritoneal and hemodialysis patients
Public title
effect of N-acetylcysteine in the treatment of peritoneal dialysis and hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: treating with dialysis for more than 3 months ;having more than 100 mL urine in 24 hours.
Exclusion Criteria: treating with dialysis for less than 3 months; having acute renal failure; being currently treated with antioxidants such as vitamins E, C.; being anuric (less than 100 mL urine in 24 hours).
Age
From 18 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Tehran University of Medical Science, Poursina street, Qods street, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2014-01-26, 1392/11/06
Ethics committee reference number
93-1-14-24508
Health conditions studied
1
Description of health condition studied
chronic kidney disease stage 5
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
24hr urine volume
Timepoint
days 0, 15, 30, 45, 60, 75, 90
Method of measurement
measuring 24hr urine volume with graded container
2
Description
Glomerular filtration rate (GFR)
Timepoint
before study (day 0)and at the end of study (day 90)
Method of measurement
24hr urine volume test and evaluating mean of urea and creatinin clearance according to formula in the questionaire
3
Description
KT/V
Timepoint
before study (day 0) and at the end of study (day 90)
Method of measurement
measuring urea before and after dialysis
Secondary outcomes
1
Description
fasting plasma glucose
Timepoint
before study and monthly till the end of the study
Control group received only standard treatment including antihypertensive drugs, vitamin B, statin, asprin for a period of three month.
Category
Treatment - Drugs
2
Description
Intervention group received eff tab NAC 1200 mg BD other than standard treatment (including antihypertensive drugs, vitamin B, statin, asprin) for three month.