Investigation the Effect of Q10 and N-acetyl Cysteine antioxidants on reducing the Incidence of Acute Kidney Injury in high risk Patients Admitted to PICU
1. Effect of N-acetyl cysteine on the prevalence of acute kidney injury in children admitted to PICU
2. Effect of Q10 on the prevalence of acute kidney injury in children admitted to PICU
3. Comparison of the effect of N-acetyl cysteine and Q10 on reducing the prevalence of acute kidney injury in children admitted to PICU
Design
A randomized, double blinded clinical trial study with community-based and pragmatic control group, and parallel groups
Settings and conduct
Before the study, a questionnaire will be prepared which contains data on demographic information of the patients (including age, sex, weight and height, and etc.). After patients selection based on inclusion and exclusion criteria, the initial concentrations serum of Cr and BUN in all patients will be recorded and evaluated. Patients will be randomly divided into 3 groups, including NAC (n=30), Q10 (n=30), and placebo (n=30). During the survey, serum levels of Cr and BUN will be measured and evaluated periodically based on RIFLE criteria. The other vital parameters such as blood pressure, weight of patients, CBC, and electrolytes will be carefully considered and controlled.
Participants/Inclusion and exclusion criteria
children without history of kidney disease and getting minimum score 10 from PRISM 3 scoring table will be selected for this survey. Children who have chronic kidney diseases will be excluded from the study. Furthermore, child's who have to use some types of drugs which have interference with the study drugs will be excluded from the survey. children shouldn’t participate in another study at a same time and they will be excluded in case they present sensitivity to the study drugs.
Intervention groups
A group receiving NAC antioxidant
A group receiving Q10 antioxidant
A placebo group
Main outcome variables
NAC and Q10 effect on prevalence of acute kidney injury in children admitted to PICU
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180801040661N1
Registration date:2019-01-12, 1397/10/22
Registration timing:registered_while_recruiting
Last update:2019-01-12, 1397/10/22
Update count:0
Registration date
2019-01-12, 1397/10/22
Registrant information
Name
Maryam sakhaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2304 6253
Email address
sakhaei.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation the Effect of Q10 and N-acetyl Cysteine antioxidants on reducing the Incidence of Acute Kidney Injury in high risk Patients Admitted to PICU
Public title
Effect of Q10 and N-acetyl Cysteine antioxidants on Acute Kidney Injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Filling out the informed consents form by child parents
No history of renal failure
Getting minimum score number 10 from PRISM3 scoring table
Exclusion criteria:
Children who have had kidney failure before the study
Use of drugs that have interference with the study
Contribution in another study at a same time
The presence of side effects caused by study drugs
Age
From 1 month old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Random Sampling
Blinding (investigator's opinion)
Double blinded
Blinding description
In this survey, children's parents know about the study drugs, but they will not be informed about grouping. The grouping will be clarified with A, B and C, and drugs will not be identified by all persons except researcher and disciplinary committee for data supervision.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-11-17, 1397/08/26
Ethics committee reference number
IR.IUMS.FMD.REC.1397.081
Health conditions studied
1
Description of health condition studied
Acute kidney injury disease
ICD-10 code
N17.9
ICD-10 code description
Acute kidney failure, unspecified
Primary outcomes
1
Description
The important outcome of the current survey is the effect of NAC and Q10 in prevention of AKI which is performed by measuring several factors such as urine volume, blood urea nitrogen, creatinine, hemoglobin, white blood cells, platelet, sodium, potassium, phosphor, calcium and magnesium elements, as well as consideration of glomerular filtration in the kidney.
Timepoint
Patients in NAC group will receive 8mg/kg/TDS NAC and patients in Q10 will be treated with 3 mg/kg/day Q10 during admission time at PICU.
Method of measurement
Blood urea , creatinine, hemoglobin, white blood cells, sodium, potassium, will be measured using ELISA method. AKI disease severity will be evaluated using RIFLE standard criterion.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first intervention group includes recipients of n-acetyl cysteine who will receive 8mg/kg/TDS NAC during admission time at PICU
Category
Treatment - Drugs
2
Description
Intervention group: The second intervention group includes recipients of Q10 who will receive 3 mg/kg/day Q10 during admission time at PICU
Category
Treatment - Drugs
3
Description
Control group: The control group includes recipients of placebo who will receive placebo during admission time at PICU
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat-e- Ali Asghar Hospital
Full name of responsible person
Dr. Maryam Sakhaei
Street address
N197, Hazrat e Ali asghar children hospital, vahid dastgerdi st , Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2222 2041
Email
sakhaei.m@iums.ac.ir
Web page address
http://crtha.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
seyed Kazem Malakouti
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
malakouti.k@iums.ac.ir
Web page address
http://vcr.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Sakhaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 193, Hazrat e Ali asghar children hospital, Vahid dastgerdi st, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Fax
Email
sakhaei.m@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Sakhaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 193, Hazrat e Aliasghar children hospital, Vahid dastgerdi st, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Fax
Email
sakhaei.m@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Sakhaei
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
No. 193, Hazrat e Ali asghar children hospital, Vahid dastgeri st, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1919816766
Phone
+98 21 2304 6253
Fax
Email
sakhaei.m@iums.ac.ir
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Documents of clinical tests results before and after treatments, along with demographic information of patients will be presented. However, personal details of the patient's such as their address and contact details are secret and will not be presented.
When the data will become available and for how long
Access to the documents will be provided 6 months after the publication of the results.
To whom data/document is available
People working at university, hospitals and pharmaceutical companies with official license
Under which criteria data/document could be used
Further documents of these patients can be presented with written permission in order to diagnosis and treatment of the disease.
From where data/document is obtainable
To get data information you can contact using the following address:
Dr. Maryam Sakhaei,
Hazrat-e- Ali Asghar Hospital
Tel: 09122882596
Email: sakhaei.m@iums.ac.ir
What processes are involved for a request to access data/document
Upon requesting, the principal researcher will consider it and consult with the research supervisors and other collaborators to reach a final decision. This process may take several weeks.