1. Home
  2. Approved trials
  3. » فارسی

Effects of Taurine Powder Supplementation on Inflammatory Markers and Clinical Outcomes in Traumatic Brain Injury Patients Admitted to the Intensive Care Unit

Protocol summary

Study aim
Determination of the effects of supplementation of Taurine powder on inflammatory markers and clinical implications in patients with traumatic brain injury admitted to the intensive care unit
Design
This study is a clinical trial randomized, double blind and parallel, will be carried out on 44 patients with traumatic brain injury,who are eligible for inclusion criteria and admitted to the intensive care unit of Golestan Hospital in Ahvaz. Patients are randomly divided into two groups.
Settings and conduct
this study is a double-blind clinical trial with the aim of evaluating the effect of taurine powder supplementation on inflammatory markers and clinical outcomes in traumatic brain injury patients admitted to intensive care unit at Golestan Hospital, Ahvaz. Neither patients nor the investigator are aware of the fact of receiving or not receiving Taurin, and the gavage of patients is prepared by a third person. Patients at the beginning and at the end of the study are taking 10 ml of venous blood to determine serum levels of IL-6, IL-10, TNF-a and hs-CRP.
Participants/Inclusion and exclusion criteria
At least 18 years old, Patients with traumatic brain injury with GCS = 6-12, receiving entral nutrition. The patient should not be pregnant or breastfeeding, lack of liver or kidney disorders, The patient has not received anti-inflammatory drugs or corticosteroids before entering the study. lack of congenital amino acid disorder. More than 60% of energy and protein requirements are calculated during the first week by enteral nutrition.
Intervention groups
Intervention: Standard Gavage powder for Karen pharma and taurine powder with a dose of 30 mg /kg body weight divided in two doses for 14 days Control : Standard Gavage powder for Karen pharma for 14 days
Main outcome variables
IL-6, IL-10, TNF-a, hs-CRP, weight,disease severity, malnutrition,Time of connecting to the ventilator

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180514039657N1
Registration date: 2018-06-22, 1397/04/01
Registration timing: registered_while_recruiting

Last update: 2018-06-22, 1397/04/01
Update count: 0
Registration date
2018-06-22, 1397/04/01
Registrant information
Name
mahsa vahdat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3373 8253
Email address
vahdat.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-10, 1397/03/20
Expected recruitment end date
2019-01-10, 1397/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Taurine Powder Supplementation on Inflammatory Markers and Clinical Outcomes in Traumatic Brain Injury Patients Admitted to the Intensive Care Unit
Public title
effects of taurine in traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old GCS=6-12 traumatic brain injury patients receive entral nutrition
Exclusion criteria:
Taking anti-inflammatory drugs or corticosteroids before entering the study Patients with liver or kidney disorders Pregnant or lactating women Patients with Congenital Amino Acid Metabolism Disorder Failure to provide more than 60% of the energy and protein requirement calculated through entral nutrition in the first week
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients to each groups is done by random block method using block of size 6.In order to ensure that the selection bias does not occur, the allocation method is used to allocate a unique code to each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
the type of blinding in our study is double-blind. Taurine powder is dissolved by an individual except the researcher in the gavage solution and is coded as A and B, so that the investigator will not be informed of the patient's receipt or not of Taurine. Patients are randomly allocated to each group A and B.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2018-01-27, 1396/11/07
Ethics committee reference number
IR.AJUMS.REC.1396.919

Health conditions studied

1

Description of health condition studied
traumatic brain injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury

Primary outcomes

1

Description
high sensitive C-Reactive Protein
Timepoint
The beginning and end of the study
Method of measurement
ELISA

2

Description
Tumor Necrosis Factor-alpha
Timepoint
The beginning and end of the study
Method of measurement
ELISA

3

Description
Interleukin-6
Timepoint
The beginning and end of the study
Method of measurement
ELISA

4

Description
Interleukin-10
Timepoint
The beginning and end of the study
Method of measurement
ELISA

5

Description
weight
Timepoint
The beginning and end of the study
Method of measurement
Patient bedside scale

6

Description
Clinical outcome measurement
Timepoint
day 1,7,14
Method of measurement
Sequential Organ Failure Assessment(SOFA) score

7

Description
disease severity
Timepoint
day 1,14
Method of measurement
APACHEII score

Secondary outcomes

1

Description
30-day mortality
Timepoint
day 30
Method of measurement
Contact with patient's family

2

Description
length of stay to ICU
Timepoint
daily
Method of measurement
observation

3

Description
malnutrition
Timepoint
The beginning and end of the study
Method of measurement
subjective global assessment

4

Description
Dependence on ventilator
Timepoint
daily
Method of measurement
Counting the number of ventilator attachment days

Intervention groups

1

Description
Intervention group: standard entrameal of karen pharma with taurine powder with a dose 30 mg/kg in two divided doses per day for 14 days
Category
Treatment - Drugs

2

Description
Control group: standard entrameal of karen pharma for 14 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
mahsa vahdat
Street address
Ahvaz Golestan hospital, Golestan Blvd, Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
vahdat.m@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Vice Chancellor for Research and Technology,Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd, Ahvaz
City
ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 7570
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Vahdat
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Paramedicine, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3321 4578
Email
vahdat.m@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Seyyed Ahmad Hosseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Paramedical School,Ahvaz Jundishapur University of Medical Sceinces, Golestan Blvd, Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3333 3050
Email
seyedahmadhosseini@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mahsa Vahdat
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Paramedicine, Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6135815751
Phone
+98 61 3321 4578
Email
vahdat.m@ajums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
If the decision is to publicate the data, after the unidentified individuals all data will be publicated.
When the data will become available and for how long
The access period will be 6 months after the publication of the results.
To whom data/document is available
Researchers working in academic and industrial institutions can apply to get data.
Under which criteria data/document could be used
To cite. Referring to reference or researcher's permission
From where data/document is obtainable
Mahsa Vahdat. Faculty of Paramedicine, jundishapur University of Medical Sciences, golestan Blvd, Ahvaz. vahdat.m@ajums.ac.ir
What processes are involved for a request to access data/document
Access to articles related to this research Send email to the responsible author
Comments
Loading...