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

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Drug: Dexmedetomidine; Drug: Vitamin D3

• Registration Number: NCT06565338
• Lead Sponsor: Minia University

Brief 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

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 Timeline

• Study Start: 2021-04-25
• Primary Completion: 2023-12-25
• Study Completion: 2024-02-05
• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-01
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group A	Dexmedetomidine	dexmedetomidine 0.4 mic/kg loading dose then 0.25 mic/kg/hr for 5 days
group B	Vitamin D3	vitamin D 100.000 IU given IM once

Primary Outcome Measures

Name	Time	Method
The primary endpoint aims to measure the inflammatory markers level:	5 days	1- IL-6 in the unit of (pg/mL).
Primary outcome measure	5 days	3- CRP in the unit of (mg/L).

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints aim to compare ICU stay, morbidity and mortality in both groups:	3 months	1- ICU stay (no. Of days)
Secondary outcome measure	3 month	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)

Trial Locations

Locations (1)

Asmaa; 🇪🇬 Minya, Egypt