Effect of N - acetylcysteine in the prevention of ototoxicity caused by vancomycin in the treatment of peritonitis in patients undergoing peritoneal dialysis.
The aim of this study is to investigate the possible protective effects of N - acetylcysteine on the incidence of hearing damage caused by vancomycin in the treatment of peritonitis in patients undergoing peritoneal dialysis. Iinclusion criteria are the patients who undergoing peritoneal dialysis and have peritonitis. Exclusion criteria is the patients who have hearing damage before our study. After informed consent is obtained , 60 patients under peritoneal dialysis with peritonitis are enrolled. All patients treated by I.P. vancomycin within ISPD protocol. Patients were divided into two groups : Groups recving N - acetylcysteine (30 patients) and those who do not take N - acetylcysteine (30 patients). Patients undergoing audiometric studies at frequencies of 250 , 500 , 1000 , 2000 , 3000 , 4000 , 6000 and 8000. The control group treated with vancomycin and other group treated with I.P. vancomycin and N - acetylcystein oraly 600 mg BID. After 21 day treatment period , two groups undergoing audiometric studies and hearing impairment will be assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202148032N2
Registration date:2013-07-09, 1392/04/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-07-09, 1392/04/18
Registrant information
Name
Sima Abediazar
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 7054
Email address
abediazars@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-09-28, 1391/07/07
Expected recruitment end date
2013-11-28, 1392/09/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of N - acetylcysteine in the prevention of ototoxicity caused by vancomycin in the treatment of peritonitis in patients undergoing peritoneal dialysis.
Public title
Effect of N - Acetylcysteine in the prevention of ototoxicity caused by vancomycin.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria : Patients with peritoneal dialysis because of kidney problems ; Patients who do not use ototoxic drugs ; Patients who have no previous hearing impairment
Exclusion criteria : Baseline audiometry with hearing damage ; Patients who use other ototoxic drugs
Age
No age limit
Gender
Both
Phase
N/A
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
Tabriz University of Medical Sciences
Street address
Tabriz - University Ave. - Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2012-12-17, 1391/09/27
Ethics committee reference number
91194
Health conditions studied
1
Description of health condition studied
Peritonitis
ICD-10 code
K65.9
ICD-10 code description
Peritonitis, unspecified
Primary outcomes
1
Description
Autotoxicity
Timepoint
Baseline and 21 days after treatment with N-acetylcysteine
Method of measurement
Audiometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Receiving vancomycin intraperitoneal 1g q 5 days plus N – acetylcysteine 600 mg BID orally for 21 days.
Category
Treatment - Drugs
2
Description
Control: Receiving vancomycin intraperitoneal 1g q 5 days for 21 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Of Nephrology, Imam Reza Hospital
Full name of responsible person
Sima Abediazar
Street address
Imam Reza Hospital, Golgasht Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistance Of Tabriz University Of Medical Science
Full name of responsible person
Mohammad Reza Rashidi
Street address
Research Assistance, Tabriz University Of Medical Science, Golgasht Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistance Of Tabriz University Of Medical Science
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
Tabriz University Of Medical Science
Full name of responsible person
Sima Abediazar
Position
Nephrologist/Associate Professor
Other areas of specialty/work
Street address
Office Of Internal Medicine Group, Imam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
abediazars@tbzmed.ac.ir, dr.emamipour@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Science
Full name of responsible person
Sima Abediazar
Position
Nephrologist/Associate Professor
Other areas of specialty/work
Street address
Office Of Internal Medicine Group, Imam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1334 7054
Fax
Email
abediazars@tbzmed.ac.ir,dr.emamipour@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Science
Full name of responsible person
Mina Emamipour
Position
Internal Medicine Assistant
Other areas of specialty/work
Street address
Office Of Internal Medicine Group, Imam Reza Hospital, Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1332 9494
Fax
Email
dr.emamipour@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)