Assiut university hospital
Asyut, Assuit, Assuit universi, Egypt
Location status: Recruiting
NCT Number: NCT05323149
In this study, our aim is to investigate the role of Dexamethasone for modulating the inflammation in patients with traumatic brain injury (TBI).
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 3
Asyut, Assuit, Assuit universi, Egypt
Location status: Recruiting
This is double-blind trial, where group D will be received Dexamethasone, where group C will be received saline placebo.
In emergency room (ER), trauma patients will be assessed and managed according to our local hospital protocol. After the initial resuscitation of patients. The selection was done according to the inclusion criteria. Baseline investigations
Group D, will be received Dexamethasone (loading dose of 10 mg in 5 ml saline, followed by a 8 mg in 5 ml saline of maintenance dose every 6 hours for 48 h). Group C, will be received saline (loading dose of 5 ml saline 0.9%, followed by a 5 ml saline 0.9% of maintenance saline dose every 6 hours for 48 h) to monitor the post-interventional inflammatory response (CBC for NLR, PLR), CRP, IL-6, C-reactive protein/Albumin ratio (CAR), hemostasis (PC, PT, activated PTT, and international normalized ratio (INR)) and short-term outcome. Conscious level will be assessed by Glasgow come scale (GCS), delirium by Richmond Agitation-Sedation Scale (RASS score) and hemodynamics will be continuously monitored. Patients will be monitored and managed in intermediate or intensive care unit. Adverse effects and complications will be recorded and managed.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Giving 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).
Other names: Normal saline
Giving 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).
Time frame: 48 hours post-interventional (either placebo or Dexamethasone)
Percentage of patients with decreased the inflammatory response, as assessed by NLR measurements
Interested in participating?
Request InfoAssiut University
Other
The Impact of Early Use of Dexamethasone Traumatic Brain Injury Upon the Inflammatory Response and Outcome
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.
Published trials that share one or more normalized conditions with this study.
NCT05880524
Brain Diseases, Cardiovascular Diseases
Munich, Bavaria, Germany
View Trial DetailsNCT06450704
Behavior, Depressive Disorder
Alcalá de Henares, Madrid, Spain
View Trial DetailsNCT05875740
Infections, Inflammation
Wuhan, Hubei, China
View Trial DetailsNCT07566832
Aging, Inflammatory Response
Taipei, Taiwan
View Trial Details