AnesthesiaPhase 3NCT06846307
The Effect of Mannitol Volume With Changes in Osmolarity in Traumatic Brain Injury
A Phase 3 study testing Mannitol in people with Anesthesia and Traumatic Brain Injury, run by Universitas Diponegoro at 1 site in Indonesia.
Trial summary
This observational study is designed to research the effect of mannitol volume administration with changes in osmolarity in patients with traumatic brain injury to guide the safe use of mannitol in these patients. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Traumatic Brain Injury
- What is being tested?
- Mannitol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Nov 2023to 31 Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-40 years
- Glasgow Coma Scale (GCS) score indicating mild (14-13) or moderate (12-10)
Who cannot join
- Renal impairment
- Multiple trauma with bleeding shock
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mannitol Volume Administration With Changes in Osmolarity in Traumatic Brain Injury: An Observational Study
This observational study is designed to research the effect of mannitol volume administration with changes in osmolarity in patients with traumatic brain injury to guide the safe use of mannitol in these patients.
Read the detailed description
This prospective observational cohort study included 64 non-operative TBI patients admitted to Dr. Kariadi Central General Hospital, Semarang, Indonesia, between November 2023 and January 2024. Patients received one of three routine clinical regimens: 3×0.25 g/kg, 2×0.5 g/kg, or 3×0.5 g/kg body weight. Mannitol was administered intravenously over 15-20 minutes per dose. Plasma osmolarity was measured at baseline and at 6 and 24 hours following initial administration.
- Conditions
- Anesthesia, Traumatic Brain Injury
- Being tested
- Mannitol
- Keywords
- brain injury, intracranial pressure, mannitol, neurocritical care, osmolarity, trauma
- Medical subject headings
- Brain Injuries, Traumatic, Brain Injuries, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MannitolDrug
Also called Otsu-Mannitol 20
mannitol administration across all three dosages given as an IV drip for 15-20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Mannitol 1 | Active comparator | 3×0.25 g/kg Receives: Drug: Mannitol |
| Mannitol 2 | Active comparator | 2×0.5 g/kg Receives: Drug: Mannitol |
| Mannitol 3 | Active comparator | 3×0.5 g/kg Receives: Drug: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osmolarity
Blood osmolarity (mOsm/L)
Measured: At baseline (before administration) and subsequently at 6 hours and 24 hours post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Nov 2023
- Primary completion29 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taufik Saputra, Universitas Diponegoro
- Investigators
- Aria P Hayanto, Sp.An-TI, Study director, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846307
- Sponsor's protocol ID
- 1554/EC/KEPK-RSDK/2023
- Status last verified
- Jun 2026
- First submitted
- 4 Feb 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mannitol Volume Administration With Changes in Osmolarity in Traumatic Brain Injury: An Observational Study
- ClinicalTrials.gov ID
- NCT06846307
- Acronym / sponsor ID
- 1554/EC/KEPK-RSDK/2023
- Conditions
- Anesthesia, Traumatic Brain Injury
- Keywords
- brain injury, intracranial pressure, mannitol, neurocritical care, osmolarity, trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 26 Feb 2025 (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.
This observational study is designed to research the effect of mannitol volume administration with changes in osmolarity in patients with traumatic brain injury to guide the safe use of mannitol in these patients.
Detailed description
This prospective observational cohort study included 64 non-operative TBI patients admitted to Dr. Kariadi Central General Hospital, Semarang, Indonesia, between November 2023 and January 2024. Patients received one of three routine clinical regimens: 3×0.25 g/kg, 2×0.5 g/kg, or 3×0.5 g/kg body weight. Mannitol was administered intravenously over 15-20 minutes per dose. Plasma osmolarity was measured at baseline and at 6 and 24 hours following initial administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mannitol 1 | Active comparator | Drug: Mannitol3×0.25 g/kg |
| Mannitol 2 | Active comparator | Drug: Mannitol2×0.5 g/kg |
| Mannitol 3 | Active comparator | Drug: Mannitol3×0.5 g/kg |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients aged 18-40 years
- Glasgow Coma Scale (GCS) score indicating mild (14-13) or moderate (12-10)
Key exclusion criteria (3 listed)
- Renal impairment
- Multiple trauma with bleeding shock
- Diabetes mellitus
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 |
|---|---|---|
| MannitolAlso: Otsu-Mannitol 20mannitol administration across all three dosages given as an IV drip for 15-20 minutes | Drug | Mannitol 1, Mannitol 2, Mannitol 3 |
Primary outcome
Osmolarity
Time frame: At baseline (before administration) and subsequently at 6 hours and 24 hours post-administration
Blood osmolarity (mOsm/L)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Aria P Hayanto, Sp.An-TI study director
Universitas Diponegoro
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 Mannitol in people with Anesthesia and Traumatic Brain Injury, run by Universitas Diponegoro at 1 site in Indonesia.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 11 Jun 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 Indonesia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osmolarity (time frame: At baseline (before administration) and subsequently at 6 hours and 24 hours post-administration). 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 11 Jun 2026.