Intracranial HypertensionPhase 4NCT00447018
Mannitol Versus Hypertonic Saline Solution in the Treatment of Elevated Intracranial Pressure
A Phase 4 study testing 20% mannitol and 7.45% hypertonic saline solution in people with Intracranial Hypertension, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The purpose of this study is to determine whether mannitol is as effective as hypertonic saline solution in the treatment of elevated intracranial pressure in patients with brain injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hypertension
- What is being tested?
- 20% mannitol and 7.45% hypertonic saline solution
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2002to Jun 2005
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or older
- sustained elevated intracranial pressure to more than 20 mmHg for more than 10 min
- mechanically ventilated in stable conditions for more than 2 hours prior to the study
- serum osmolality ranged between 280 and 320 mOsm/kg
Who cannot join
- imminent cranial or extracranial surgery
- leakage or drainage of cerebral spinal fluid
- unstable respiratory and hemodynamic conditions
- oliguric renal failure
- anemia
- use of mannitol or HSS in the previous 6 hours
- concomitant use of thiopentone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Equimolar Doses of Mannitol and Hypertonic Saline in the Treatment of Elevated Intracranial Pressure
The purpose of this study is to determine whether mannitol is as effective as hypertonic saline solution in the treatment of elevated intracranial pressure in patients with brain injury.
Read the detailed description
Elevation of intracranial pressure (ICP) to more than 20 mmHg plays a major role in the worsening of the neurological status through the impairment of brain perfusion. In an effort to reduce the intensity and the time spent with increased ICP, infusion of mannitol has been the recommended first-line agent for years. The growing interest in the use of hypertonic saline solutions (HSS) in this clinical setting has, however, challenged the use of mannitol. Because mannitol and HSS may differ regarding their clinically relevant mechanisms of action, there is a need to determine which osmotic compound could be the most appropriate in patients with elevated ICP. We conduct thus a parallel, randomized controlled trial comparing the effects of an equimolar infusion of 20% mannitol or 7.45% HSS without colloid in patients with elevated ICP. The primary end point of this trial is the magnitude of ICP and of cerebral perfusion pressure (CPP) changes following treatment during a study period of 120 min.
- Conditions
- Intracranial Hypertension
- Being tested
- 20% mannitol, 7.45% hypertonic saline solution
- Keywords
- intracranial pressure, mannitol, hypertonic saline solution, brain injury, traumatic brain injury, Adult patients, With elevation of intracranial pressure (ICP > 20 mmHg)
- Medical subject headings
- Intracranial Hypertension, Brain Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% mannitolDrug
7.45% hypertonic saline solutionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of ICP and of cerebral perfusion pressure (CPP) changes following osmotherapy during a study period of 120 min.
Secondary outcomes (3)
Effects of treatment on blood flow velocities (FV) of middle cerebral artery using continuous transcranial doppler.
Effects of treatment on brain oxygenation using brain tissue oxygen tension (PbrO2) probe.
Effects of treatment on biochemical data (serum sodium and osmolality, urine output).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startOct 2002
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intracranial HypertensionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Investigators
- Jean-Francois Payen, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447018
- Sponsor's protocol ID
- 0224
- Status last verified
- Mar 2007
- First submitted
- 12 Mar 2007
- Last updated
- 13 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Battison C, Andrews PJ, Graham C, Petty T. Randomized, controlled trial on the effect of a 20% mannitol solution and a 7.5% saline/6% dextran solution on increased intracranial pressure after brain injury. Crit Care Med. 2005 Jan;33(1):196-202; discussion 257-8. doi: 10.1097/01.ccm.0000150269.65485.a6.
PubMed 15644669Vialet R, Albanese J, Thomachot L, Antonini F, Bourgouin A, Alliez B, Martin C. Isovolume hypertonic solutes (sodium chloride or mannitol) in the treatment of refractory posttraumatic intracranial hypertension: 2 mL/kg 7.5% saline is more effective than 2 mL/kg 20% mannitol. Crit Care Med. 2003 Jun;31(6):1683-7. doi: 10.1097/01.CCM.0000063268.91710.DF.
PubMed 12794404
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Equimolar Doses of Mannitol and Hypertonic Saline in the Treatment of Elevated Intracranial Pressure
- ClinicalTrials.gov ID
- NCT00447018
- Acronym / sponsor ID
- 0224
- Conditions
- Intracranial Hypertension
- Keywords
- intracranial pressure, mannitol, hypertonic saline solution, brain injury, traumatic brain injury, Adult patients, With elevation of intracranial pressure (ICP > 20 mmHg)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2002
- Study completion
- Jun 2005
- First posted
- 13 Mar 2007 (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.
The purpose of this study is to determine whether mannitol is as effective as hypertonic saline solution in the treatment of elevated intracranial pressure in patients with brain injury.
Detailed description
Elevation of intracranial pressure (ICP) to more than 20 mmHg plays a major role in the worsening of the neurological status through the impairment of brain perfusion. In an effort to reduce the intensity and the time spent with increased ICP, infusion of mannitol has been the recommended first-line agent for years. The growing interest in the use of hypertonic saline solutions (HSS) in this clinical setting has, however, challenged the use of mannitol. Because mannitol and HSS may differ regarding their clinically relevant mechanisms of action, there is a need to determine which osmotic compound could be the most appropriate in patients with elevated ICP. We conduct thus a parallel, randomized controlled trial comparing the effects of an equimolar infusion of 20% mannitol or 7.45% HSS without colloid in patients with elevated ICP. The primary end point of this trial is the magnitude of ICP and of cerebral perfusion pressure (CPP) changes following treatment during a study period of 120 min.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 or older
- sustained elevated intracranial pressure to more than 20 mmHg for more than 10 min
- mechanically ventilated in stable conditions for more than 2 hours prior to the study
- serum osmolality ranged between 280 and 320 mOsm/kg
Key exclusion criteria (7 listed)
- imminent cranial or extracranial surgery
- leakage or drainage of cerebral spinal fluid
- unstable respiratory and hemodynamic conditions
- oliguric renal failure
- anemia
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 |
|---|---|---|
| 20% mannitol | Drug | – |
| 7.45% hypertonic saline solution | Drug | – |
Primary outcome
Magnitude of ICP and of cerebral perfusion pressure (CPP) changes following osmotherapy during a study period of 120 min.
3 secondary outcomes
Effects of treatment on blood flow velocities (FV) of middle cerebral artery using continuous transcranial doppler.
Effects of treatment on brain oxygenation using brain tissue oxygen tension (PbrO2) probe.
Effects of treatment on biochemical data (serum sodium and osmolality, urine output).
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 13 Mar 2007.
- Results publication: PubMed 15644669Battison C, Andrews PJ, Graham C, Petty T. Randomized, controlled trial on the effect of a 20% mannitol solution and a 7.5% saline/6% dextran solution on increased intracranial pressure after brain injury. Crit Care Med. 2005 Jan;33(1):196-202; discussion 257-8. doi: 10.1097/01.ccm.0000150269.65485.a6.
- Results publication: PubMed 12794404Vialet R, Albanese J, Thomachot L, Antonini F, Bourgouin A, Alliez B, Martin C. Isovolume hypertonic solutes (sodium chloride or mannitol) in the treatment of refractory posttraumatic intracranial hypertension: 2 mL/kg 7.5% saline is more effective than 2 mL/kg 20% mannitol. Crit Care Med. 2003 Jun;31(6):1683-7. doi: 10.1097/01.CCM.0000063268.91710.DF.
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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.
Jean-Francois Payen, MD, PhD 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 20% mannitol and 7.45% hypertonic saline solution in people with 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 4 inclusion and 7 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 13 Mar 2007. 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 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?
Magnitude of ICP and of cerebral perfusion pressure (CPP) changes following osmotherapy during a study period of 120 min.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00447018, which also lists 2 linked publications.
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 13 Mar 2007; AzTrials last refreshed its copy on 1 Nov 2026.