Evaluation of the effect of high doses of selenium on oxidative stress status and inflammatory factors in post gastrointestinal surgery children in intensive care unit
Determination of the effect of high doses of selenium on oxidative stress status and inflammatory factors in post gastrointestinal surgery children in intensive care unit
Design
Randomized parallel group clinical trial
Single blinded
Method of randomization : block
Unit of randomization : individual
Randomization strata in stratified randomization:
age (>/< 1 year) and surgery (upper/ lower GI)
Tools used in randomization: table of random numbers
Allocation concealment will carried out
Target sample size: 70
Settings and conduct
Blinding: participants, nurses, Data analyser
supplement and placebo will be similar in volume and shape.
Participants/Inclusion and exclusion criteria
Patients undergoing major gastrointestinal surgery at the Akbar Hospital of Mashhad and admitted to the intensive care unit due to medical indications
Intervention groups
Intervention group: Selenium supplementation will continue to be given at a dose of 20 μg / kg / d for 10 days or until discharge from the intensive care unit or death. High-dose selenium content will be injected intravenously 20 cc of dextrose 5% in 60 minutes.
Control group: The placebo(serum: dextrose 5% ) with the same volume and shape as the control group will be administered, for 10 days or until discharge from the intensive care unit or death.
Evaluation of the effect of high doses of selenium on oxidative stress status and inflammatory factors in post gastrointestinal surgery children in intensive care unit
Public title
effect of selenium on oxidative stress status and inflammatory factors in post gastrointestinal surgery children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
0-10 years old patients undergoing major gastrointestinal surgery at the Akbar Hospital of Mashhad
Admission to the intensive care unit due to medical indications
Filling out the informed consent form by a parent or legal guardian
Stability of hemodynamic and metabolic status in the first 24 to 48 hours
Exclusion criteria:
Patients who are not allowed to start a nutrition support care for them within the first 24-48 hours
Diagnosed autoimmune disorders
Diagnosed cancers
Severe sepsis at the admission time
History of chemotherapy and radiotherapy in the past month
Diagnosed renal failure
Diagnosed severe hepatic failure
Severe and active bleeding
A known case of human immunodeficiency virus
Preterm neonates
Age
From 1 day old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization : block
Unit of randomization : individual
Randomization strata in stratified randomization:
age (>/< 1 year) and surgery (upper/ lower GI)
Tools used in randomization: table of random numbers
Allocation concealment will carried out
Blinding (investigator's opinion)
Single blinded
Blinding description
With the exception of a pharmacist,corresponding physician and investigator the supplement/ placebo assignment will be concealed from the patients, nursing system, data analyser and safety monitoring board throughout the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Science
Street address
Campus of University (Paradise Daneshgah), Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.553
Health conditions studied
1
Description of health condition studied
Digestive System Surgical Procedures
ICD-10 code
K56.60
ICD-10 code description
Unspecified intestinal obstruction
2
Description of health condition studied
selenium deficiency
ICD-10 code
E64.8
ICD-10 code description
Sequelae of other nutritional deficiencies
3
Description of health condition studied
Congenital diaphragmatic hernia
ICD-10 code
Q79.0
ICD-10 code description
Congenital diaphragmatic hernia
4
Description of health condition studied
Acute abdomen
ICD-10 code
R10.0
ICD-10 code description
Acute abdomen
5
Description of health condition studied
Congenital malformations of esophagus
ICD-10 code
Q39
ICD-10 code description
Congenital malformations of esophagus
6
Description of health condition studied
Other specified congenital malformations of upper alimentary tract
ICD-10 code
Q40
ICD-10 code description
Other congenital malformations of upper alimentary tract
7
Description of health condition studied
Congenital disorders of small intestine
ICD-10 code
Q41
ICD-10 code description
Congenital absence, atresia and stenosis of small intestine
8
Description of health condition studied
Congenital disorders of large intestine
ICD-10 code
Q42
ICD-10 code description
Congenital absence, atresia and stenosis of large intestine
9
Description of health condition studied
Congenital malformations of gallbladder, bile ducts and liver
ICD-10 code
Q44
ICD-10 code description
Congenital malformations of gallbladder, bile ducts and liver
Primary outcomes
1
Description
Pro-oxidant- Antioxidant Balance (PAB) status
Timepoint
before intervention and after 10 days
Method of measurement
Pro-oxidant- Antioxidant Balance (PAB) assay
2
Description
inflammatory factors
Timepoint
before intervention and after 10 days
Method of measurement
Interleukin 1 beta: ELISA, high-sensitivity C-reactive protein (hs-CRP) test: Immunoturbidimetry
Secondary outcomes
1
Description
Serum and urine selenium Level
Timepoint
before intervention and 1, 10 days after intervention
Method of measurement
atomic absorpsion
2
Description
Serum Glutathione peroxidase level
Timepoint
before intervention and 1, 10 days after intervention
Method of measurement
ELISA
Intervention groups
1
Description
Intervention group: Selenium supplementation will continue to be given at a dose of 20 μg / kg / d for 10 days or until discharge from the intensive care unit or death. High-dose selenium content will be injected intravenously 20 cc of dextrose 5% in 60 minutes. Injectable selenium in sodium selenite form with a concentration of 50 μg / ml by the Pharmacy school of Mashhad University of Medical Sciences will be used.
Category
Treatment - Other
2
Description
Control group: The placebo(serum: dextrose 5% ) with the same volume and shape as the intervention group, for 10 days or until discharge from the intensive care unit or death.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Akbar hospital
Full name of responsible person
Dr. Gholamreza Khademi
Street address
Shahid Kaveh boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98 51 3871 3801
Email
KhademiGH@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Deputy of Research and Technology of the University, Qoreishi Center, Daneshgah street.
City
mashhad
Province
Razavi Khorasan
Postal code
13131 - 99137
Phone
+98 51 3841 1538
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Roudi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Mashhad University of Medical Sciences (MUMS) Campus of University (Paradise Daneshgah), Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98 51 3800 2423
Fax
Email
roudif951@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Roudi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Mashhad University of Medical Sciences (MUMS) Campus of University (Paradise Daneshgah), Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98 51 3800 2423
Fax
Email
roudif951@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Roudi
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Nutrition
Street address
Mashhad University of Medical Sciences (MUMS) Campus of University (Paradise Daneshgah), Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
91779-48564
Phone
+98 51 3800 2423
Fax
Email
roudif951@mums.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The non-identifiable individual participant data collected in this study will be shared. Also, The protocol, results, and statistical analysis of the current study will be published in the relevant articles.
When the data will become available and for how long
The non-identifiable individual participant data will become available after the publication of the relevant articles.
To whom data/document is available
they will be available for people working in academic institutions and people working in businesses can also apply to receive it.
Under which criteria data/document could be used
The non-identifiable individual participant data can only be used for research.
From where data/document is obtainable
The non-identifiable individual participant data will be obtainable by sending an e-mail to Dr. Mohsen Nematy. ( e-mail address: NematyM@mums.ac.ir)
What processes are involved for a request to access data/document
Other researchers in academic institutions can send their request by e-mail to Dr. Mohsen Nematy. The data will be sent to them after consulting and approving the research team.