Traumatic Brain InjuryNCT06565338
Comparison Between Effect of Vitamin D Versus Dexmedetomidine in Patients with Head Trauma Using Interleukin 6
An observational study of Traumatic Brain Injury, run by Minia University at 1 site in Egypt.
Trial summary
in this study the investigators compare between the neuroprotective effect of vitamin d versus dexmedetomidine in patients with traumatic brain injury using interleukin 6 as inflammatory biomarker Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Dexmedetomidine and Vitamin D3
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Apr 2021to 5 Feb 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: patients with traumatic brain injury with GCS 8-12
Who may be able to join
- Both Gender.
- Age (18-50)
- GCS (8-12)
- Pt with traumatic brain insult who not indicated surgical intervention
Who cannot join
- Prior severe disability.
- Isolated brain system lesions.
- History of underlying neurologic, metabolic or psychiatric disorders.
- Alcohol or drug abuse.
- Pregnancy.
- Patients with intracranial hemorrhage who indicated surgical evacuation.
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- Multisystem life-threatening trauma.
- GCS > 12 \& <8.
- Vitamin d deficiency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Neuroprotective Effect of Vitamin D Versus Dexmedetomidine in Patients with Traumatic Brain Injury Using Interleukin 6 As Inflammatory Marker
in this study the investigators compare between the neuroprotective effect of vitamin d versus dexmedetomidine in patients with traumatic brain injury using interleukin 6 as inflammatory biomarker
Read the detailed description
patients with moderate head trauma (GCS 8-12) within first 24 hours were randomly divided into 2 groups, first group received 100,000 IU of vitamin D was given IM \& the other group received dexmedetomidine 0.4 mic/kg as loading dose then 0.25 mic/kg/hr as maintainence dose for 5 days detecting APATCHE at admission and following up of vital signs (HR \& NIBP) \& investigations (CBC \& RFT\& ABG \& ESR\& CRP \& IL-6) \& GCS and GOS for 5 days.
- Conditions
- Traumatic Brain Injury
- Being tested
- Dexmedetomidine, Vitamin D3
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called precedex
drug
Vitamin D3Drug
Also called depovit - decaprino
drug
| Study group | Role | What they receive |
|---|---|---|
| group A | dexmedetomidine 0.4 mic/kg loading dose then 0.25 mic/kg/hr for 5 days Receives: Drug: Dexmedetomidine | |
| group B | vitamin D 100.000 IU given IM once Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint aims to measure the inflammatory markers level:
1- IL-6 in the unit of (pg/mL).
Measured: 5 days
Primary outcome measure
2- ESR in the unit of(mm/hr).
Measured: 5 days
Primary outcome measure
3- CRP in the unit of (mg/L).
Measured: 5 days
Secondary outcomes (2)
The secondary endpoints aim to compare ICU stay, morbidity and mortality in both groups:
1- ICU stay (no. Of days)
Measured: 3 months
Secondary outcome measure
2- Glascow outcome scale (1-5) : that determine morbidity and mortality (units on scale from 1 to 5 with better scale towards 5 and worse towards 1)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start25 Apr 2021
- Primary completion25 Dec 2023
- Study completion5 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, asmaa elhelw, Minia University
- Investigators
- ahmed ezz, Study chair, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565338
- Sponsor's protocol ID
- 403
- Status last verified
- Nov 2024
- First submitted
- 30 Jul 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Neuroprotective Effect of Vitamin D Versus Dexmedetomidine in Patients with Traumatic Brain Injury Using Interleukin 6 As Inflammatory Marker
- ClinicalTrials.gov ID
- NCT06565338
- Acronym / sponsor ID
- 403
- Conditions
- Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 25 Dec 2023 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 21 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
in this study the investigators compare between the neuroprotective effect of vitamin d versus dexmedetomidine in patients with traumatic brain injury using interleukin 6 as inflammatory biomarker
Detailed description
patients with moderate head trauma (GCS 8-12) within first 24 hours were randomly divided into 2 groups, first group received 100,000 IU of vitamin D was given IM \& the other group received dexmedetomidine 0.4 mic/kg as loading dose then 0.25 mic/kg/hr as maintainence dose for 5 days detecting APATCHE at admission and following up of vital signs (HR \& NIBP) \& investigations (CBC \& RFT\& ABG \& ESR\& CRP \& IL-6) \& GCS and GOS for 5 days.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | Drug: Dexmedetomidinedexmedetomidine 0.4 mic/kg loading dose then 0.25 mic/kg/hr for 5 days |
| group B | – | Drug: Vitamin D3vitamin D 100.000 IU given IM once |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients with traumatic brain injury with GCS 8-12
Key inclusion criteria (4 listed)
- Both Gender.
- Age (18-50)
- GCS (8-12)
- Pt with traumatic brain insult who not indicated surgical intervention
Key exclusion criteria (9 listed)
- Prior severe disability.
- Isolated brain system lesions.
- History of underlying neurologic, metabolic or psychiatric disorders.
- Alcohol or drug abuse.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: precedexdrug | Drug | group A |
| Vitamin D3Also: depovit - decaprinodrug | Drug | group B |
Primary outcome
The primary endpoint aims to measure the inflammatory markers level:
Time frame: 5 days
1- IL-6 in the unit of (pg/mL).
Primary outcome measure
Time frame: 5 days
2- ESR in the unit of(mm/hr).
Primary outcome measure
Time frame: 5 days
3- CRP in the unit of (mg/L).
2 secondary outcomes
The secondary endpoints aim to compare ICU stay, morbidity and mortality in both groups:
Time frame: 3 months
Secondary outcome measure
Time frame: 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed ezz study chair
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint aims to measure the inflammatory markers level: (time frame: 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.