OsmotherapyPhase 4NCT01745081
Comparison of 20% Mannitol and 3% Hypertonic Saline for Cerebral Relaxation During Elective Supratentorial Craniotomies
A Phase 4 study testing 20% mannitol bolus administration and Hypertonic saline 3% bolus administration in people with Osmotherapy and Intracranial Pressure, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Mannitol 20% has long been used to treat elevated intracranial hypertension in trauma and intensive care settings. More recent data indicate that hypertonic saline may be as effective or more effective than mannitol for this purpose, with possible fewer side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osmotherapy, Intracranial Pressure
- What is being tested?
- 20% mannitol bolus administration and Hypertonic saline 3% bolus administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Sep 2014
- 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
- Patients scheduled for elective supratentorial craniotomy for tumor resection
- Presumed preoperative diagnosis of : astrocytoma (any grade), meningioma (any sub-type) or cerebral metastasis (any primary neoplasm)
Who cannot join
- Age < 18 years
- Reintervention
- Glasgow coma scale < 13
- Emergency surgery or American Association of Anesthesiologists physical status class 4 or 5
- Prone or lateral positioning
- Hypo or hypernatremia (serum sodium below 135 or above 150 meq/L)
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- Osmotherapy (either mannitol or hypertonic saline) given in the last 24 hours
- Congestive heart failure (LVEF < 40% or restrictive diastolic dysfunction on echocardiography)
- Chronic renal failure (creatinine clearance < 30 ml/min)
- Pregnancy
- Obesity (BMI > 40)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H5N4
18193461110
About this study
Official title: Comparison of the Efficacy Between 20% Mannitol and 3% Hypertonic Saline, Given as a Bolus at the Beginning of Elective Supratentorial Craniotomy for Tumor Resection, in Favoring Cerebral Relaxation Evaluated by a Sub-dural Intracranial Pressure Measurement.
Mannitol 20% has long been used to treat elevated intracranial hypertension in trauma and intensive care settings. More recent data indicate that hypertonic saline may be as effective or more effective than mannitol for this purpose, with possible fewer side effects.
This study compares both agents in favoring cerebral relaxation during elective supratentorial procedures for tumor resection.
Study hypothesis: 3% hypertonic saline will provide better cerebral relaxation with fewer side effects than 20% mannitol.
- Conditions
- Osmotherapy, Intracranial Pressure
- Being tested
- 20% mannitol bolus administration, Hypertonic saline 3% bolus administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20% mannitol bolus administrationDrug
Hypertonic saline 3% bolus administrationDrug
| Study group | Role | What they receive |
|---|---|---|
| Mannitol | Experimental | Bolus mannitol 20% at skin incision Receives: Drug: 20% mannitol bolus administration |
| Hypertonic saline | Experimental | Hypertonic saline 3% at skin incision Receives: Drug: Hypertonic saline 3% bolus administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sub-dural intracranial pressure
Sub-dural measure of intracranial pressure to evaluate cerebral relaxation
Measured: In average 30-60 minutes after intervention, just before dura mater opening
Secondary outcomes (2)
Subjective evaluation of cerebral relaxation
Subjective evaluation by the surgeon of cerebral relaxation on a 4 point scale
Measured: In average 30-60 minutes after intervention, just after dura mater opening
Serum lactate
Serum lactate measurement to assess tissue perfusion during the procedure
Measured: In average 5-8 hours after intervention, upon arrival in the intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsmotherapyStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stéphane Coutu, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745081
- Sponsor's protocol ID
- Study on cerebral relaxation
- Status last verified
- Dec 2012
- First submitted
- 5 Dec 2012
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy Between 20% Mannitol and 3% Hypertonic Saline, Given as a Bolus at the Beginning of Elective Supratentorial Craniotomy for Tumor Resection, in Favoring Cerebral Relaxation Evaluated by a Sub-dural Intracranial Pressure Measurement.
- ClinicalTrials.gov ID
- NCT01745081
- Acronym / sponsor ID
- Study on cerebral relaxation
- Conditions
- Osmotherapy, Intracranial Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 7 Dec 2012 (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.
Mannitol 20% has long been used to treat elevated intracranial hypertension in trauma and intensive care settings. More recent data indicate that hypertonic saline may be as effective or more effective than mannitol for this purpose, with possible fewer side effects.
This study compares both agents in favoring cerebral relaxation during elective supratentorial procedures for tumor resection.
Study hypothesis: 3% hypertonic saline will provide better cerebral relaxation with fewer side effects than 20% mannitol.
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 |
|---|---|---|
| Mannitol | Experimental | Drug: 20% mannitol bolus administrationBolus mannitol 20% at skin incision |
| Hypertonic saline | Experimental | Drug: Hypertonic saline 3% bolus administrationHypertonic saline 3% at skin incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for elective supratentorial craniotomy for tumor resection
- Presumed preoperative diagnosis of : astrocytoma (any grade), meningioma (any sub-type) or cerebral metastasis (any primary neoplasm)
Key exclusion criteria (11 listed)
- Age < 18 years
- Reintervention
- Glasgow coma scale < 13
- Emergency surgery or American Association of Anesthesiologists physical status class 4 or 5
- Prone or lateral positioning
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 bolus administration | Drug | Mannitol |
| Hypertonic saline 3% bolus administration | Drug | Hypertonic saline |
Primary outcome
Sub-dural intracranial pressure
Time frame: In average 30-60 minutes after intervention, just before dura mater opening
Sub-dural measure of intracranial pressure to evaluate cerebral relaxation
2 secondary outcomes
Subjective evaluation of cerebral relaxation
Time frame: In average 30-60 minutes after intervention, just after dura mater opening
Serum lactate
Time frame: In average 5-8 hours after intervention, upon arrival in the intensive care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 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.
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 bolus administration and Hypertonic saline 3% bolus administration in people with Osmotherapy and Intracranial Pressure, run by Université de Sherbrooke at 1 site in Canada.
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 11 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: status not confirmed, as of the sponsor's last update on 7 Dec 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphane Coutu, MD, FRCPC (8193461110 ext. 14950, stephane.coutu@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sub-dural intracranial pressure (time frame: In average 30-60 minutes after intervention, just before dura mater opening). 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 7 Dec 2012.