Glutamine and Traumatic Brain Injury

NCT05569993 | Unknown Early Phase 1

• 1 other identifier: Traumatic brain injury
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

• The duration of ICU stay

  The duration of ICU stay after glutamine adiminstration

  First 30 days

Secondary Outcomes (2)

• Consiousness level by Glagow coma scale

  30 days

• The incidence of Convulsions

  30 days

Study Arms (2)

Glutamine group

ACTIVE COMPARATOR

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

Drug: Glutamine

Placcebo group

PLACEBO COMPARATOR

30 patients will recieve placcebo for first 7 days in ICU

Other: Placcebo

Interventions

Glutamine DRUG

.3 mg/kg of glutamine

Glutamine group

Placcebo OTHER

Patients will recieve placcebo

Placcebo group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 60 years old
• mild to moderate head trauma

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Links

• Related Info
• Related Info
• 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
• Related Info

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• Mohamed Hassan Bakri, Professor

  Assiut University

  STUDY CHAIR

• Emad Zarief Kamel, Assistant professor

  Assiut University

  STUDY DIRECTOR

Central Study Contacts

Engy Raafat Youssif, Master student

CONTACT

01226016909; Engiraafat95@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Double blinded clinical trial Masking for patient,their relatives and outcome assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecuturer

Model Details: 2 groups will recieve glutamine ,the other will be placcebo group

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 6, 2022
• Study Start: October 30, 2022
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 6, 2022

Record last verified: 2022-10