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Glutamine and Traumatic Brain Injury

Primary Purpose

Brain Injuries, Traumatic

Status
Not yet recruiting
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Glutamine
Placcebo
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries, Traumatic

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 18 to 60 years old
  • mild to moderate head trauma

Exclusion Criteria:

  • patients with concurrent cns dysfunction
  • Renal failure patient
  • diabetic patients with neuropathy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Glutamine group

    Placcebo group

    Arm Description

    30 patients will recieve .3 mg/kg of glutamine for first 7 days in ICU

    30 patients will recieve placcebo for first 7 days in ICU

    Outcomes

    Primary Outcome Measures

    The duration of ICU stay
    The duration of ICU stay after glutamine adiminstration

    Secondary Outcome Measures

    Consiousness level by Glagow coma scale
    Glasgow coma scale improvement
    The incidence of Convulsions
    Convulsions controled by glutamine

    Full Information

    First Posted
    September 30, 2022
    Last Updated
    October 5, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05569993
    Brief Title
    Glutamine and Traumatic Brain Injury
    Official Title
    Does Glutamine Therapy Have a Positive Effect on Traumatic Brain Injury Patients?Double Blinded Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 30, 2022 (Anticipated)
    Primary Completion Date
    October 30, 2023 (Anticipated)
    Study Completion Date
    December 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Glutamate is an important neurotransmitter present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system. Glutamate is a non-essential amino acid with restricted passage to the brain from the blood. In the CNS, glutamate is synthesised in neurons as part of the glutamate-glutamine cycle.5,6 so it plays an essential role in normal brain functioning and can improve situations related to impaired cognitive,motor and emotional functions and can be used to improve traumatic brain injury patient general health status
    Detailed Description
    The term "brain injury" covers a wide range of conditions and injuries relating to the brain, skull, and scalp. A traumatic brain injury (TBI) usually results when the head or body suffers from a violent blow or jolt that results in swelling, bruising, bleeding, or tearing of the brain tissue which any damage to it has the potential to change the way your body operates. Now ,(TBI) is considered one of the major causes of disability and deaths ,As It contributes more than 30% Of deaths worldwide . Those who survive a TBI can face effects that last a few days, or the rest of their lives. Effects of TBI can include impaired motor, cognitive and emotional functioning. These issues not only affect individuals but can have lasting effects on families and communities.TBI can also cause some inflammatory mediators to be released in circulation that affect brain and systemic organs such as cortisol,IL6 and TNF etc. A lot of modialities have been introduced to help in decreasing these side effects. Glutamine,a non-essential amino acid present abundantly throughout the body and is involved in many metabolic processes. It is synthesized from glutamic acid and ammonia. It is the principal carrier of nitrogen in the body and is an important energy source for many cells.glutamine has a restricted passage to the brain from blood but it is synthesised in the brain as a part of the glutamate-glutamine cycle.5,6 so it present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system,maintaining normal brain function and can improve situations related to impaired cognitive,motor and emotional functions. Hypothesis of this study; Does glutamine therapy have a positive effect on traumatic brain injury patients ?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Injuries, Traumatic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    2 groups will recieve glutamine ,the other will be placcebo group
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Double blinded clinical trial Masking for patient,their relatives and outcome assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Glutamine group
    Arm Type
    Active Comparator
    Arm Description
    30 patients will recieve .3 mg/kg of glutamine for first 7 days in ICU
    Arm Title
    Placcebo group
    Arm Type
    Placebo Comparator
    Arm Description
    30 patients will recieve placcebo for first 7 days in ICU
    Intervention Type
    Drug
    Intervention Name(s)
    Glutamine
    Intervention Description
    .3 mg/kg of glutamine
    Intervention Type
    Other
    Intervention Name(s)
    Placcebo
    Intervention Description
    Patients will recieve placcebo
    Primary Outcome Measure Information:
    Title
    The duration of ICU stay
    Description
    The duration of ICU stay after glutamine adiminstration
    Time Frame
    First 30 days
    Secondary Outcome Measure Information:
    Title
    Consiousness level by Glagow coma scale
    Description
    Glasgow coma scale improvement
    Time Frame
    30 days
    Title
    The incidence of Convulsions
    Description
    Convulsions controled by glutamine
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 to 60 years old mild to moderate head trauma Exclusion Criteria: patients with concurrent cns dysfunction Renal failure patient diabetic patients with neuropathy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Engy Raafat Youssif, Master student
    Phone
    01226016909
    Email
    Engiraafat95@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mohamed Hassan Bakri, Professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Emad Zarief Kamel, Assistant professor
    Organizational Affiliation
    Assiut University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Links:
    URL
    https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.mayoclinic.org/diseases-conditions/traumatic-brain-injury/symptoms-causes/syc-20378557&ved=2ahUKEwj03c7No736AhWJgP0HHWbdB_AQFnoECAsQAQ&usg=AOvVaw1hApNyp5Z15Rb6ZV9Bsz6j
    Description
    Related Info
    URL
    https://www.google.com/url?sa=t&source=web&rct=j&url=https://my.clevelandclinic.org/health/articles/22839-glutamate&ved=2ahUKEwj6lYmLpb36AhV0hv0HHXvCBlYQFnoECCsQAQ&usg=AOvVaw0I8zh85AIWxxVmICDoKYAD
    Description
    Related Info
    URL
    https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.frontiersin.org/articles/10.3389/fnhum.2021.722323/full&ved=2ahUKEwj6lYmLpb36AhV0hv0HHXvCBlYQFnoECDAQAQ&usg=AOvVaw1Tp_hCCgkjNJLx_761AVQx
    Description
    https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4133642/&ved=2ahUKEwj6lYmLpb36AhV0hv0HHXvCBlYQFnoECEIQAQ&usg=AOvVaw1_kGwGwx5h2G2svqnAp1SJ
    URL
    https://www.google.com/url?sa=t&source=web&rct=j&url=https://medlineplus.gov/traumaticbraininjury.html&ved=2ahUKEwik8NOwpb36AhVUgP0HHZ9xDvQQFnoECEQQAQ&usg=AOvVaw1xT2gGMsCPiHuu0ZAFDDID
    Description
    Related Info

    Learn more about this trial

    Glutamine and Traumatic Brain Injury

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