Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT05569993
Status:
UNKNOWN
Last Update Posted:
2022-10-06
First Post:
2022-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glutamine and Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005973', 'term': 'Glutamine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D021542', 'term': 'Amino Acids, Neutral'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double blinded clinical trial Masking for patient,their relatives and outcome assessor'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '2 groups will recieve glutamine ,the other will be placcebo group'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-05', 'studyFirstSubmitDate': '2022-09-30', 'studyFirstSubmitQcDate': '2022-10-05', 'lastUpdatePostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The duration of ICU stay', 'timeFrame': 'First 30 days', 'description': 'The duration of ICU stay after glutamine adiminstration'}], 'secondaryOutcomes': [{'measure': 'Consiousness level by Glagow coma scale', 'timeFrame': '30 days', 'description': 'Glasgow coma scale improvement'}, {'measure': 'The incidence of Convulsions', 'timeFrame': '30 days', 'description': 'Convulsions controled by glutamine'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Brain Injuries, Traumatic']}, 'referencesModule': {'seeAlsoLinks': [{'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', 'label': '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', 'label': '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', 'label': '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', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.\n\nGlutamate 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', 'detailedDescription': '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.\n\nNow ,(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.\n\nGlutamine,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.\n\nHypothesis of this study; Does glutamine therapy have a positive effect on traumatic brain injury patients ?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 60 years old\n* mild to moderate head trauma\n\nExclusion Criteria:\n\n* patients with concurrent cns dysfunction\n* Renal failure patient\n* diabetic patients with neuropathy'}, 'identificationModule': {'nctId': 'NCT05569993', 'briefTitle': 'Glutamine and Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Does Glutamine Therapy Have a Positive Effect on Traumatic Brain Injury Patients?Double Blinded Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Traumatic brain injury'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glutamine group', 'description': '30 patients will recieve .3 mg/kg of glutamine for first 7 days in ICU', 'interventionNames': ['Drug: Glutamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placcebo group', 'description': '30 patients will recieve placcebo for first 7 days in ICU', 'interventionNames': ['Other: Placcebo']}], 'interventions': [{'name': 'Glutamine', 'type': 'DRUG', 'description': '.3 mg/kg of glutamine', 'armGroupLabels': ['Glutamine group']}, {'name': 'Placcebo', 'type': 'OTHER', 'description': 'Patients will recieve placcebo', 'armGroupLabels': ['Placcebo group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Engy Raafat Youssif, Master student', 'role': 'CONTACT', 'email': 'Engiraafat95@gmail.com', 'phone': '01226016909'}], 'overallOfficials': [{'name': 'Mohamed Hassan Bakri, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}, {'name': 'Emad Zarief Kamel, Assistant professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecuturer', 'investigatorFullName': 'Engy Raafat Youssif', 'investigatorAffiliation': 'Assiut University'}}}}