Comparison of the Effectiveness of High-protein Nutritional regimes with Normal regimes on Neuronal Bio-markers and Clinical Outcome of Neurocritical Patients
Determination of the effect of high protein diet (1.5 to 2 mg/kg/day) on serum level of Neuron specific Enolase (NSE) and Transthyretin, Nitrogen Balance and Glasgow Outcome Scale Extended in neurocritical patients
Design
Two arm parallel group randomized trial (control and intervention groups), not blinded and outcome assessment
Settings and conduct
Neurocretic patients admitted to the intensive care unit of Imam Hossein Hospital in Tehran are divided into two intervention and control groups and evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients older than 16 years old who have one of the following factors and stay in ICU for 5 days. (Subarachnoid Hemorrhage, Subdural Hematoma, Traumatic brain injury, Aneurysm, Intracranial hemorrhage, Others
Exclusion criteria:
Patient's death during the first three days of study
Patient dis-admit with personal satisfaction within the first three days
Disapprove of the patient to enter the research
Contraindication of receiving high protein die
Hepatic Encephalopathy
An allergy to the drug
Consumer of Warfarin
Pregnancy
Metabolic disorders (gout, phenylketonuria)
Chronic renal failure
Proteinuria is higher than 3 grams per day
Intervention groups
Intervention group: Receiving high protein diet (1.5 to 2 mg per kg daily)
Control group: Receiving Regular diet of the intensive care unit
Main outcome variables
serum level of Neuron specific Enolase (NSE)
serum level of Transthyretin
Nitrogen Balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120703010178N14
Registration date:2018-04-11, 1397/01/22
Registration timing:registered_while_recruiting
Last update:2018-04-11, 1397/01/22
Update count:0
Registration date
2018-04-11, 1397/01/22
Registrant information
Name
Mohammad Sistanizad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 0087
Email address
sistanizadm@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2019-09-20, 1398/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of High-protein Nutritional regimes with Normal regimes on Neuronal Bio-markers and Clinical Outcome of Neurocritical Patients
Public title
Effect of high protein regime in nurocritical patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 16 years old who have one of the following factors and stay in ICU for 5 days.
Subarachnoid Hemorrhage
Subdural Hematoma
Traumatic brain injury
Aneurysm
Intracranial hemorrhage
Others
Exclusion criteria:
Patient's death during the first three days of study
Patient dis-admit with personal satisfaction within the first three days
Disapprove of the patient to enter the research
Contraindication of receiving high protein die
Hepatic encephalopathy
An allergy to the drug
Consumer of Warfarin
Pregnancy
Metabolic disorders (gout, phenylketonuria)
Chronic renal failure
Proteinuria is higher than 3 grams per day
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The method of assigning each regimen to patients is randomized and random blocked blocks with block size 6 (using a permuted block randomization table).
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 committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2017-12-30, 1396/10/09
Ethics committee reference number
IR.SBMU.PHNM.1396.879
Health conditions studied
1
Description of health condition studied
Diseases of the nervous system injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury
Primary outcomes
1
Description
Neuron Specific Enolase
Timepoint
At the beginning of the intervention (before the intervention) and 3 and 5 days after the beginning of the intervention
Method of measurement
Enolase CanAg kit
2
Description
Serum Transtreatin Level
Timepoint
At the beginning of the intervention (before the intervention) and 3 and 5 days after the beginning of the intervention
Method of measurement
Prealbumin Minineph *25T
3
Description
Nitrogen Balance
Timepoint
At the beginning of the intervention (before the intervention) and 5 days after the beginning of the intervention
Method of measurement
Based on urea concentration
Secondary outcomes
1
Description
Extended Glasgow Outcome Scale
Timepoint
The end of the first, second and third months after the begining intervention
Method of measurement
Score of Extended Glasgow Outcome Scale
2
Description
mortality
Timepoint
The end of the first, second and third months after the begining intervention
Method of measurement
Will be checked by phone
3
Description
Effect of medication on neuron specific Enolase
Timepoint
At the beginning of the intervention (before the intervention) and 3 and 5 days after the beginning of the intervention
Method of measurement
Blood sample
4
Description
Effect of medication on serum prealbumin level
Timepoint
At the beginning of the intervention (before the intervention) and 3 and 5 days after the beginning of the intervention
Method of measurement
blood sample
5
Description
Effect of medication on nitrogen balance
Timepoint
At the beginning of the intervention (before the intervention) and 5 days after the beginning of the intervention
Method of measurement
Urine sample
Intervention groups
1
Description
Intervention group: Prescribing protein (1.5-2 mg/kg/day) for 5 days
Category
Treatment - Other
2
Description
Control group: Prescribing a regular diet in the intensive care unit for 5 days
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Intensive care unit, Imam Hussein medical center
Full name of responsible person
Mohammad Sistanizad
Street address
Shahid Madani Street
City
Theran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 0087
Email
sistanizadm@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Tahereh Shams
Street address
Velenjak Street, Shahid Chamran High Way
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 23 87121
Email
info@sbmu.ac.ir
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
Mohammad Sistanizad
Position
Assistant Professor / Clinical Pharmacy Specialist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 0087
Email
sistanizadm@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammad Sistanizad
Position
Assistant Professor, Clinical Pharmacy Specialist
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218820087
Email
sistanizadm@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Forouzan Ahmadpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Niayesh Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
Ahmadpourforoz@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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