Comparison Between Effect of Vitamin D Versus Dexmedetomidine in Patients with Head Trauma Using Interleukin 6

Minia University60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Traumatic Brain Injury

Interventions

DexmedetomidineDRUG

drug

Vitamin D3DRUG

drug

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Both Gender. * Age (18-50) * GCS (8-12) * Pt with traumatic brain insult who not indicated surgical intervention Exclusion Criteria: * 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. * Multisystem life-threatening trauma. * GCS \> 12 \& \<8. * Vitamin d deficiency.

Locations (1)

Asmaa

Minya, Minya Governorate, Egypt

Outcomes

Primary Outcomes

The primary endpoint aims to measure the inflammatory markers level:

1- IL-6 in the unit of (pg/mL).

Time frame: 5 days

Primary outcome measure

2- ESR in the unit of(mm/hr).

Time frame: 5 days

Primary outcome measure

3- CRP in the unit of (mg/L).

Time frame: 5 days

Secondary Outcomes

The secondary endpoints aim to compare ICU stay, morbidity and mortality in both groups:

1- ICU stay (no. Of days)

Time frame: 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)

Time frame: 3 month

Data from ClinicalTrials.gov

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