evaluating the effect of vitamin E on colisitn associated nephrotoxicity
Design
Randomized controlled trial
Settings and conduct
Loghman-hakim hospitalized patients
Participants/Inclusion and exclusion criteria
study population consist of hospitalized patients who have bacteremia with positive blood cluture for multi-drug resistance gram negative organism which is sensitive to colisitn, Pneumonia with positive trocheal cluture for multi-drug resistance gram negative organism which is sensitive to colisitn, urinary tract infection with positive urinary cluture for multi-drug resistance gram negative organism which is sensitive to colisitn or meningitis with cerebrospinal fluid cluture for multi-drug resistance gram negative organism which is sensitive to colisitn.
Intervention groups
patients will receive vitamin E to prevent or decrease colistin associated nephrotoxicity with the dose of 400 IU/day concomitantly with colistin
Patients in control group will receive colistin without receiving vitamin E during study period.
Faculty of pharmacy, Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
z.sahraei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Administration of Vitamin E on Colistin Associated Nephrotoxicity in Treatment of Drug Resistance Gram Negative Bacterial Infections
Public title
The Effects of Administration of Vitamin E on Colistin Associated Nephrotoxicity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
candidate to receive colistin to treat infection with positive blood culture for multi-drug resistance gram negative organism which is sensitive to colistin
pneumonia with positive tracheal culture for multi-drug resistance gram negative organism which is sensitive to colistin
urinary tract infection with positive urinary culture for multi-drug resistance gram negative organism which is sensitive to colistin
meningitis with positive Cerebrospinal fluid culture for multi-drug resistance gram negative organism which is sensitive to colistin
receiving colistin for at least one week
Exclusion criteria:
Chronic kidney disease
Acute kidney injury
Receiving amphotericin B
Receiving intravenous ascorbic acid
Active bleeding
Pregnancy
Patient's death
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation sequence will computer generate and consist of series of group number (either 1 = A or 2 = B) for each consecutive patient. Block randomization method will use and each block will be consist of 10 patients. Each block includes 5 patients who will receive Vitamin E and 5 patients from control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Shahid Beheshti University of Mediacl Sciences
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Approval date
2019-01-29, 1397/11/09
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1397.207
Health conditions studied
1
Description of health condition studied
colistin associated nephrotoxicity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum creatinine
Timepoint
baseline then daily to the end of colistin administration
Method of measurement
blood sample
2
Description
glomerular filtration rate
Timepoint
baseline then daily to the end of colistin administration
Method of measurement
Cockcroft-Gault Formula
3
Description
Blood urea nitrogen
Timepoint
baseline then daily to the end of colistin administration
Method of measurement
blood sample
4
Description
Urinary output
Timepoint
baseline then daily to the end of colistin administration
Method of measurement
Measuring patient's urine volume
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive vitamin E in (alpha tocopherol) by dose of 400 IU/day in form of four 100 IU chewable tablets which will be chew by patients or will be crushed and feed to the patient by nasogasteric tube. Vitamin E will be administered concomitantly by colistin at least for 7 days
Category
Treatment - Drugs
2
Description
Control group: Patients won't receive vitamin E concomitantly with colistin
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Loghman-hakim hospital
Full name of responsible person
Dr.Zahra Sahraei, Assitant professor of Clincal Pharmacy
Street address
Makhsoos St, South Karegar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 5102 5000
Email
zahra.sahraei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Nima Naderi
Street address
Faculty of Pharmacy-Niyayesh intersection-Valiasr St
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
zahra.sahraei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Omid Moradi
Position
Clinical Pharmacy Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
O_moradi@outlook.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Zahra Sahraei
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0209
Email
zahra.sahraei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.Omid Moradi
Position
Clinical Pharmacy Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Niayesh Highway, Valiasr Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1991953381
Phone
+98 21 8820 0118
Email
O_moradi@outlook.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Primary outcome data after making unrecognizable will be released
When the data will become available and for how long
6 months after publishing the results primary outcome data will be released
To whom data/document is available
Researchers after allowance of corresponding author could have the permission to have the data
Under which criteria data/document could be used
Performing any analysis will be allowed only with the permission of corresponding author
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document
After requesting to reach data, corresponding author will check the allowance, then the researcher will be informed about it