The main aim of this study is to evaluate the efficacy of N-acetylcysteine in the prevention of amphotericin B-induced nephrotoxicity. Sixty adult patients are randomized to receive N-acetylcysteine (600 mg orally twice daily) (n = 30) or placebo (600 mg orally twice daily) (n = 30) during the period of amphotericin B treatment. Demographic data, primary admission diagnosis, concomitant disease(s) and co-administered medication(s) are recorded. Blood and urine sampling are performed at baseline (before starting amphotericin B) and weekly thereafter during amphotericin B treatment. Renal function test (blood urea nitrogen and creatinine), serum electrolytes (sodium, potassium, magnesium). In addition, novel markers of renal function (cystatin C and kidney injury molecule-1) are measured in serum samples at baseline, day 7, and 14 of amphotericin B treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107233449N8
Registration date:2011-08-09, 1390/05/18
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-08-09, 1390/05/18
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-09-23, 1390/07/01
Expected recruitment end date
2012-09-22, 1391/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating N-acetylcysteine efficacy in the prevention of amphotericin B-induced nephrotoxicity
Public title
Evaluating N-acetylcysteine efficacy in the prevention of amphotericin B-induced nephrotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
1- Age between 18 to 65 years
2- Hemodynamica stability (Mean arterial pressure > 70 mmHg and Systolic blood pressure > 90 mmHg)
3- Receiving AmB for treatment of fungal infections
Exclusion criteria
1- Documented history of acute kidney injury or chronic kidney disease
2- The status of kidney function at baseline is unknown
3- Receiving N-acetylcysteine (oral or parenteral) recently (during the last 1 month)
4- Documented history of hypersensitivity/anaphylactic reactions to N-acetylcysteine
5- Co-administration of antioxidants (e.g. vitamin E, vitamin C)
Age
From 18 years old to 65 years old
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)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd.,Tehran University of Medical sciences, Central organization, 6th Floor
City
Tehran
Postal code
Approval date
2011-07-23, 1390/05/01
Ethics committee reference number
90-02-33-13767
Health conditions studied
1
Description of health condition studied
Fungal infections
ICD-10 code
B37، B38 ،
ICD-10 code description
Certain infectious and parasitic diseases
Primary outcomes
1
Description
Nephrotoxicity
Timepoint
At baseline then weekly
Method of measurement
renal function tests (BUN, Cr), serum electrolytes and biomarkers (cystatine C and KIM-1)