Dexamethasone in Traumatic Brain Injury
ConditionInflammatory Response
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssiut University
About this trial
In this study, our aim is to investigate the role of Dexamethasone for modulating the inflammation in patients with traumatic brain injury (TBI).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Isolated traumatic brain injury patients (mild or moderate cases)
GCS > 8
non penetrating TBI in 8 hours onset
Age ≥ 18 years
Disqualifiers
Patient in cardiac arrest
Patients with coagulopathies
All diabetic patients
Renal failure patients
Trial design
Design model
Parallel
Treatments tested in this trial
Saline
Other interventionGiving saline 0.9% (loading dose of 5 ml of saline 0.9%, followed by a 5 ml of maintenance saline 0.9% dose every 6 hours for 48 h).
Dexamethasone
DrugGiving Dexamethasone (loading dose of 10 mg dilutedin 5 ml saline, followed by a 8 mg in 5 ml saline of maintenance dose every 6 hours for 48 h).
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Group CPlacebo comparator 1 intervention
Group B: Group DExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of patients with decreased the inflammatory response
Percentage of patients with decreased the inflammatory response, as assessed by NLR measurements
Time frame
48 hours post-interventional (either placebo or Dexamethasone)Sponsors and contacts
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Source ClinicalTrials.gov