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NCT Number: NCT06565338

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

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

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Asmaa

Minya, Minya Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

drug

Other names: precedex

Vitamin D3

Drug

drug

Other names: depovit - decaprino

Primary outcomes

  1. The primary endpoint aims to measure the inflammatory markers level:

    Time frame: 5 days

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

  2. Primary outcome measure

    Time frame: 5 days

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

  3. Primary outcome measure

    Time frame: 5 days

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

Secondary outcomes

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

    Time frame: 3 months

    1- ICU stay (no. Of days)

  2. Secondary outcome measure

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

Comparison Between the Neuroprotective Effect of Vitamin D Versus Dexmedetomidine in Patients with Traumatic Brain Injury Using Interleukin 6 As Inflammatory Marker

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Aug 21, 2024
Registry last updated
Nov 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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