Inflammatory ResponsePhase 3NCT05323149
Dexamethasone in Traumatic Brain Injury
A Phase 3 study testing Saline and Dexamethasone in people with Inflammatory Response, run by Assiut University at 1 site in Egypt.
Trial summary
In this study, our aim is to investigate the role of Dexamethasone for modulating the inflammation in patients with traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inflammatory Response
- What is being tested?
- Saline and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 18 May 2022to 15 Oct 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Isolated traumatic brain injury patients (mild or moderate cases)
- GCS > 8
- non penetrating TBI in 8 hours onset
- Age ≥ 18 years
Who cannot join
- Patient in cardiac arrest
- Patients with coagulopathies
- All diabetic patients
- Renal failure patients
- pregnancy
- Patient refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Assiut university hospital
Asyut, Assuit, Assuit universi
Omar Soliman, omar@aun.edu.eg
About this study
Official title: The Impact of Early Use of Dexamethasone Traumatic Brain Injury Upon the Inflammatory Response and Outcome
In this study, our aim is to investigate the role of Dexamethasone for modulating the inflammation in patients with traumatic brain injury (TBI).
Read the detailed description
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
- C-reactive protein (CRP), interleukin -6(IL-6), C-reactive protein/Albumin ratio (CAR), complete blood count (CBC) for neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR).
- Prothrombin concentration (PC), prothrombin time (PT), activated partial thromboplastin time (aPTT), and INR.
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.
- Conditions
- Inflammatory Response
- Being tested
- Saline, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineOther
Also called Normal saline
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).
DexamethasoneDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | Group C, will be received saline (loading dose of 5 ml of saline 0.9%, followed by a 5 ml saline 0.9% of maintenance saline dose every 6 hours for 48 h). Receives: Other: Saline |
| Group D | Experimental | Group D, will be received Dexamethasone (loading dose of 10 mg Dexamethasone in 5 ml saline, followed by a 8 mg diluted in 5 ml saline of maintenance dose every 6hours for 48 h). Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with decreased the inflammatory response
Percentage of patients with decreased the inflammatory response, as assessed by NLR measurements
Measured: 48 hours post-interventional (either placebo or Dexamethasone)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start18 May 2022
- Primary completion10 Sep 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Makram Soliman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323149
- Sponsor's protocol ID
- 17101636
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2022
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Early Use of Dexamethasone Traumatic Brain Injury Upon the Inflammatory Response and Outcome
- ClinicalTrials.gov ID
- NCT05323149
- Acronym / sponsor ID
- 17101636
- Conditions
- Inflammatory Response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 15 Oct 2027 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, our aim is to investigate the role of Dexamethasone for modulating the inflammation in patients with traumatic brain injury (TBI).
Detailed description
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
- C-reactive protein (CRP), interleukin -6(IL-6), C-reactive protein/Albumin ratio (CAR), complete blood count (CBC) for neutrophil lymphocyte ratio (NLR), platelet lymphocyte ratio (PLR).
- Prothrombin concentration (PC), prothrombin time (PT), activated partial thromboplastin time (aPTT), and INR.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Other: SalineGroup C, will be received saline (loading dose of 5 ml of saline 0.9%, followed by a 5 ml saline 0.9% of maintenance saline dose every 6 hours for 48 h). |
| Group D | Experimental | Drug: DexamethasoneGroup D, will be received Dexamethasone (loading dose of 10 mg Dexamethasone in 5 ml saline, followed by a 8 mg diluted in 5 ml saline of maintenance dose every 6hours for 48 h). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Isolated traumatic brain injury patients (mild or moderate cases)
- GCS > 8
- non penetrating TBI in 8 hours onset
- Age ≥ 18 years
Key exclusion criteria (6 listed)
- Patient in cardiac arrest
- Patients with coagulopathies
- All diabetic patients
- Renal failure patients
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SalineAlso: Normal salineGiving 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 | Group C |
| DexamethasoneGiving 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). | Drug | Group D |
Primary outcome
Percentage of patients with decreased the inflammatory response
Time frame: 48 hours post-interventional (either placebo or Dexamethasone)
Percentage of patients with decreased the inflammatory response, as assessed by NLR measurements
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saline and Dexamethasone in people with Inflammatory Response, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar Soliman (01101266040, omar@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with decreased the inflammatory response (time frame: 48 hours post-interventional (either placebo or Dexamethasone)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 5 Nov 2026.