Glutamine and Traumatic Brain Injury

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05569993

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Brain Injuries, Traumatic	Drug: Glutamine Other: Placcebo	Early Phase 1

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 ?

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

2 groups will recieve glutamine ,the other will be placcebo group2 groups will recieve glutamine ,the other will be placcebo group

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

Double blinded clinical trial Masking for patient,their relatives and outcome assessor

Primary Purpose:

Treatment

Official Title:

Does Glutamine Therapy Have a Positive Effect on Traumatic Brain Injury Patients?Double Blinded Randomized Clinical Trial

Anticipated Study Start Date :

Oct 30, 2022

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Glutamine group 30 patients will recieve .3 mg/kg of glutamine for first 7 days in ICU	Drug: Glutamine .3 mg/kg of glutamine
Placebo Comparator: Placcebo group 30 patients will recieve placcebo for first 7 days in ICU	Other: Placcebo Patients will recieve placcebo

Arm

Intervention/Treatment

Active Comparator: Glutamine group

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

Drug: Glutamine

.3 mg/kg of glutamine

Placebo Comparator: Placcebo group

30 patients will recieve placcebo for first 7 days in ICU

Other: Placcebo

Patients will recieve placcebo

Outcome Measures

Primary Outcome Measures

The duration of ICU stay [First 30 days]
The duration of ICU stay after glutamine adiminstration

Secondary Outcome Measures

Consiousness level by Glagow coma scale [30 days]
Glasgow coma scale improvement
The incidence of Convulsions [30 days]
Convulsions controled by glutamine

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Chair: Mohamed Hassan Bakri, Professor, Assiut University
Study Director: Emad Zarief Kamel, Assistant professor, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Engy Raafat Youssif, Assistant lecuturer, Assiut University

ClinicalTrials.gov Identifier:

NCT05569993

Other Study ID Numbers:

Traumatic brain injury

First Posted:

Oct 6, 2022

Last Update Posted:

Oct 6, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Brain Injuries

Brain Injuries, Traumatic

Wounds and Injuries

Study Results

No Results Posted as of Oct 6, 2022