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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | dexmedetomidine 0.4 mic/kg loading dose then 0.25 mic/kg/hr for 5 days |
| |
| group B | vitamin D 100.000 IU given IM once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint aims to measure the inflammatory markers level: | 1- IL-6 in the unit of (pg/mL). | 5 days |
| Primary outcome measure | 2- ESR in the unit of(mm/hr). | 5 days |
| Primary outcome measure | 3- CRP in the unit of (mg/L). | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary endpoints aim to compare ICU stay, morbidity and mortality in both groups: | 1- ICU stay (no. Of days) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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patients with traumatic brain injury with GCS 8-12
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| Name | Affiliation | Role |
|---|---|---|
| ahmed ezz | Minia University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asmaa | Minya | Minya Governorate | Egypt |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Vitamin D3 |
| Drug |
drug |
|
|
| 3 month |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |