Brain TumorNCT00199511
Hypertonic Saline 75% vs Mannitol 20%
A study testing Administration of Hypertonic Solution 7.5% vs Mannitol 20% in people with Brain Tumor and Tumor, Brain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the effect of Hypertonic Saline 7.5% vs Mannitol 20% on brain bulk (using a 4 point scale), intracranial pressure (subdural catheter)and the changes on serum and urinary Na, K and Osmolarity during elective craniotomy for brain tumor resection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Tumor, Tumor, Brain, Brain Neoplasm
- What is being tested?
- Administration of Hypertonic Solution 7.5% vs Mannitol 20%
- How many people
- 162 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2005to Apr 2007
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status I - 3.
- Age >18 years.
- Scheduled for elective craniotomies for supratentorial brain tumour resection.
- Written informed consent.
Who cannot join
- Within the past six months, a history of unstable angina pectoris and/or having a myocardial infarction.
- Electrocardiogram abnormalities indicating severe ischemia.
- Congestive heart failure.
- Glasgow coma sore < 9
- Refusal to participate or refusal to agree to randomization.
- Known renal failure
- Known poorly controlled diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Equiosmolar Doses of Mannitol 20% Versus Hypertonic Saline 7.5% Infusion in the Reduction of Brain Bulk During Elective Craniotomies for Supratentorial Brain Tumor Resection
The purpose of this study is to evaluate the effect of Hypertonic Saline 7.5% vs Mannitol 20% on brain bulk (using a 4 point scale), intracranial pressure (subdural catheter)and the changes on serum and urinary Na, K and Osmolarity during elective craniotomy for brain tumor resection.
Read the detailed description
Raised intracranial pressure occurs following an expansion of an intracranial mass e.g. hematoma or brain tumor and if left untreated, can lead to brain ischemia, stroke and death.
Strategies for reducing raised intracranial pressure include hyperventilation, use of a hyperosmolar agent and the evacuation of the intracranial mass.
The two hypertonic solutions most commonly used are Mannitol 20% and Hypertonic Saline 7.5%.
During elective neurosurgical removal of a brain tumour, the anesthesiologist needs to reduce intracranial pressure and provide good operating brain conditions to avoid brain ischemia.
Currently, Mannitol 20% is routinely used intra-operatively in these patients to reduce brain bulk and intracranial pressure and to improve brain operating conditions.
However, Mannitol itself can cause secondary effects that can be deleterious to the neurological patient. Mannitol causes a diuresis which may lead to systemic hypovolemia and hypotension, and adverse changes in serum and urinary sodium, potassium and osmolarity.
Experience with Hypertonic saline 7.5%, has been mainly in brain injured patients either in the Emergency Dept or in the Intensive care setting. There is growing evidence that Hypertonic saline 7.5% is just as effective as Mannitol 20% in reducing raised intracranial pressure, especially in traumatic brain injury and it has become a widely accepted form of treatment. One of the advantages of Hypertonic saline is that it does not cause a diuresis and therefore less likely to cause hypotension and hypovolemia. While transient hypernatremia has been observed after the administration of hypertonic saline, there have been no clinical consequences.
Unfortunately there have been only two studies which compared the effectiveness of Hypertonic saline and Mannitol during elective brain surgery. One of them, Gemma et al, failed to demonstrate any difference in the reduction of brain bulk between Mannitol and Hypertonic saline. However the 2 solutions used had different osmolarities and this may have had a confounding effect on the results. In the other study (published in Polish), the authors found a 20% reduction in brain bulk in favour of hypertonic saline. In view of these two opposing findings, we feel that another investigation is warranted.
- Conditions
- Brain Tumor, Tumor, Brain, Brain Neoplasm, Neoplasm, Supratentorial, Tumor, Supratentorial
- Being tested
- Administration of Hypertonic Solution 7.5% vs Mannitol 20%
- Keywords
- Brain Tumor, Intracranial Pressure, Osmolarity, Seric, Hypertonic Solution
- Medical subject headings
- Brain Neoplasms, Supratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of Hypertonic Solution 7.5% vs Mannitol 20%Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgeon's assessment of brain bulk.
ICP reduction
Secondary outcomes (2)
Changes in intracranial pressure
Changes in serum and urine levels of sodium, potassium and osmolarity.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 162 participants
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rosemary A Craen, MD, Principal investigator, Associate Proffesor UWO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199511
- Sponsor's protocol ID
- R-05-154
- Status last verified
- Nov 2018
- First submitted
- 13 Sep 2005
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Equiosmolar Doses of Mannitol 20% Versus Hypertonic Saline 7.5% Infusion in the Reduction of Brain Bulk During Elective Craniotomies for Supratentorial Brain Tumor Resection
- ClinicalTrials.gov ID
- NCT00199511
- Acronym / sponsor ID
- R-05-154
- Conditions
- Brain Tumor, Tumor, Brain, Brain Neoplasm, Neoplasm, Supratentorial, Tumor, Supratentorial
- Keywords
- Brain Tumor, Intracranial Pressure, Osmolarity, Seric, Hypertonic Solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 20 Sep 2005 (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 evaluate the effect of Hypertonic Saline 7.5% vs Mannitol 20% on brain bulk (using a 4 point scale), intracranial pressure (subdural catheter)and the changes on serum and urinary Na, K and Osmolarity during elective craniotomy for brain tumor resection.
Detailed description
Raised intracranial pressure occurs following an expansion of an intracranial mass e.g. hematoma or brain tumor and if left untreated, can lead to brain ischemia, stroke and death.
Strategies for reducing raised intracranial pressure include hyperventilation, use of a hyperosmolar agent and the evacuation of the intracranial mass.
The two hypertonic solutions most commonly used are Mannitol 20% and Hypertonic Saline 7.5%.
During elective neurosurgical removal of a brain tumour, the anesthesiologist needs to reduce intracranial pressure and provide good operating brain conditions to avoid brain ischemia.
Currently, Mannitol 20% is routinely used intra-operatively in these patients to reduce brain bulk and intracranial pressure and to improve brain operating conditions.
However, Mannitol itself can cause secondary effects that can be deleterious to the neurological patient. Mannitol causes a diuresis which may lead to systemic hypovolemia and hypotension, and adverse changes in serum and urinary sodium, potassium and osmolarity.
Experience with Hypertonic saline 7.5%, has been mainly in brain injured patients either in the Emergency Dept or in the Intensive care setting. There is growing evidence that Hypertonic saline 7.5% is just as effective as Mannitol 20% in reducing raised intracranial pressure, especially in traumatic brain injury and it has become a widely accepted form of treatment. One of the advantages of Hypertonic saline is that it does not cause a diuresis and therefore less likely to cause hypotension and hypovolemia. While transient hypernatremia has been observed after the administration of hypertonic saline, there have been no clinical consequences.
Unfortunately there have been only two studies which compared the effectiveness of Hypertonic saline and Mannitol during elective brain surgery. One of them, Gemma et al, failed to demonstrate any difference in the reduction of brain bulk between Mannitol and Hypertonic saline. However the 2 solutions used had different osmolarities and this may have had a confounding effect on the results. In the other study (published in Polish), the authors found a 20% reduction in brain bulk in favour of hypertonic saline. In view of these two opposing findings, we feel that another investigation is warranted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA physical status I - 3.
- Age >18 years.
- Scheduled for elective craniotomies for supratentorial brain tumour resection.
- Written informed consent.
Key exclusion criteria (7 listed)
- Within the past six months, a history of unstable angina pectoris and/or having a myocardial infarction.
- Electrocardiogram abnormalities indicating severe ischemia.
- Congestive heart failure.
- Glasgow coma sore < 9
- Refusal to participate or refusal to agree to randomization.
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 |
|---|---|---|
| Administration of Hypertonic Solution 7.5% vs Mannitol 20% | Drug | – |
Primary outcome
Surgeon's assessment of brain bulk.
ICP reduction
2 secondary outcomes
Changes in intracranial pressure
Changes in serum and urine levels of sodium, potassium and osmolarity.
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 6 Nov 2018.
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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.
Rosemary A Craen, MD principal investigator
Associate Proffesor UWO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of Hypertonic Solution 7.5% vs Mannitol 20% in people with Brain Tumor and Tumor, Brain, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 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 6 Nov 2018. 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.
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?
Surgeon's assessment of brain bulk.. The study lists 2 primary outcomes in all. 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 6 Nov 2018.