Traumatic Brain InjuryPhase 4NCT00795587
Comparison of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension and Cerebral Monitoring
A Phase 4 study testing variation of mannitol dose in people with Traumatic Brain Injury and Intracranial Hypertension, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury? Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Traumatic Brain Injury, Intracranial Hypertension
- What is being tested?
- variation of mannitol dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2008to Aug 2011
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults
- severe traumatic brain injury
- intracranial hypertension requiring mannitol administration
Who cannot join
- impeding neurosurgery
- hemodynamic or respiratory severe failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension
Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?
Read the detailed description
traumatic brain injury intracranial hypertension 0,4 g/ kg vs 0,8 g/ kg (randomized) on 20 minutes monitoring: ICP, transcranial doppler, brain pO2, MAP, HR, diuresis, biology duration: 2 hours
- Conditions
- Traumatic Brain Injury, Intracranial Hypertension
- Being tested
- variation of mannitol dose
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
variation of mannitol doseDrug
in case of intracranial hypertension up to 20 mmHg lasting more than 10 minutes and without nociceptive stimulation or systemic instability: injection of either 0.4 g/ kg or 0.8 g/ kg of mannitol 20% (randomized) on 20 minutes, with monitoring of neurologic, systemic and biologic datas during 120 minutes
| Study group | Role | What they receive |
|---|---|---|
| mannitol high dose | Active comparator | mannitol 20% 0,8 g/ kg on minutes Receives: Drug: variation of mannitol dose |
| mannitol low dose | Active comparator | mannitol 20% 0,4 g/ kg on minutes Receives: Drug: variation of mannitol dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial pressure
Measured: 2 hours
Secondary outcomes (7)
transcranial doppler
Measured: 2 h
brain PO2
Measured: 2h
MAP
Measured: 2h
Heart Rate
Measured: 2h
biology (blood gases, natremia, hematocrit)
Measured: 2h
diuresis
Measured: 2h
fluid requirement
Measured: 2h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: evolution of patient's care allows no more recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Francony, MD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795587
- Sponsor's protocol ID
- 0816
- Other IDs
- 2008-004979-21, 2008
- Status last verified
- Nov 2012
- First submitted
- 20 Nov 2008
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compared Effects of 2 Doses of Mannitol on Post Traumatic Intracranial Hypertension
- ClinicalTrials.gov ID
- NCT00795587
- Acronym / sponsor ID
- 0816
- Conditions
- Traumatic Brain Injury, Intracranial Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: evolution of patient's care allows no more recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 21 Nov 2008 (estimated)
- 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.
Will an increase of the dose of mannitol improve the effects on neuromonitoring in patients suffering intracranial hypertension following traumatic brain injury?
Detailed description
traumatic brain injury intracranial hypertension 0,4 g/ kg vs 0,8 g/ kg (randomized) on 20 minutes monitoring: ICP, transcranial doppler, brain pO2, MAP, HR, diuresis, biology duration: 2 hours
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mannitol high dose | Active comparator | Drug: variation of mannitol dosemannitol 20% 0,8 g/ kg on minutes |
| mannitol low dose | Active comparator | Drug: variation of mannitol dosemannitol 20% 0,4 g/ kg on minutes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults
- severe traumatic brain injury
- intracranial hypertension requiring mannitol administration
Key exclusion criteria (2 listed)
- impeding neurosurgery
- hemodynamic or respiratory severe failure
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 |
|---|---|---|
| variation of mannitol dosein case of intracranial hypertension up to 20 mmHg lasting more than 10 minutes and without nociceptive stimulation or systemic instability: injection of either 0.4 g/ kg or 0.8 g/ kg of mannitol 20% (randomized) on 20 minutes, with monitoring of neurologic, systemic and biologic datas during 120 minutes | Drug | mannitol high dose, mannitol low dose |
Primary outcome
intracranial pressure
Time frame: 2 hours
7 secondary outcomes
transcranial doppler
Time frame: 2 h
brain PO2
Time frame: 2h
MAP
Time frame: 2h
Heart Rate
Time frame: 2h
biology (blood gases, natremia, hematocrit)
Time frame: 2h
diuresis
Time frame: 2h
fluid requirement
Time frame: 2h
Results and safety
The study was stopped early (reason given: evolution of patient's care allows no more recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
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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.
Gilles Francony, MD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing variation of mannitol dose in people with Traumatic Brain Injury and Intracranial Hypertension, run by University Hospital, Grenoble at 1 site in France.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 8 Nov 2012. 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 France. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: evolution of patient's care allows no more recruitment). Results are not available in the source record.
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?
intracranial pressure (time frame: 2 hours). 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 8 Nov 2012; AzTrials last refreshed its copy on 8 Nov 2026.