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

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

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Vitamin D3

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Minya, Egypt
    • Asmaa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

patients with traumatic brain injury with GCS 8-12

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group A; dexmedetomidine 0.4 mic/kg loading dose then 0.25 mic/kg/hr for 5 days	Drug: Dexmedetomidine; drug; Other Names: precedex
group B; vitamin D 100.000 IU given IM once	Drug: Vitamin D3; drug; Other Names: depovit - decaprino

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	3 month

Collaborators and Investigators

• Sponsor: Minia University
• Investigators: Study Chair: ahmed ezz, Minia university

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2021
• Primary Completion (Actual): December 25, 2023
• Study Completion (Actual): February 5, 2024

Study Registration Dates

• First Submitted: July 30, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries, Traumatic; Brain Injuries; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Bone Density Conservation Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Micronutrients; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Vitamins; Dexmedetomidine; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes