Increased Intracranial PressurePhase 1NCT00359697
Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure
A Phase 1 study testing Hypertonic Saline, Mannitol in people with Increased Intracranial Pressure, run by Thomas Jefferson University.
Trial summary
The overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. The hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Increased Intracranial Pressure
- What is being tested?
- Hypertonic Saline, Mannitol
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 1
- 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
- Documented SAH (by computed tomography or lumbar puncture), ICH, TBI or brain tumor
- Patient greater than or equal to 18 years of age
- ICP monitor in place
- ICP greater than 20mmHg, not related to a transient noxious stimulus and not responding to standard measures for controlling ICP (ventricular drainage, elevation of head of the bed and optimizing PaCO2)
- Patient or patient's legally authorized representative has provided written informed consent
Who cannot join
- Patient less than 18 years of age
- Lack of ICP monitoring
- Patient received Mannitol prior to placement of ICP monitor
- Baseline serum osmolarity of greater than 310 mOsm/L
- Patient is currently enrolled in another investigational drug or device study
- Congestive heart failure at time of enrollment
- Chronic renal failure on hemodialysis
- Pregnancy
About this study
Official title: Prospective, Randomized Clinical Trialto Compare Mannitol and Hypertonic Saline for Treatment of Increased Intracranial Pressure
The overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. The hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol.
- Conditions
- Increased Intracranial Pressure
- Being tested
- Hypertonic Saline, Mannitol
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic Saline, MannitolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of ICP below treatment threshold (less than 20 mmHg)
Secondary outcomes (1)
Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Increased Intracranial PressureStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert H Rosenwasser, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00359697
- Sponsor's protocol ID
- 06U.132
- Status last verified
- Nov 2014
- First submitted
- 1 Aug 2006
- Last updated
- 6 Nov 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Clinical Trialto Compare Mannitol and Hypertonic Saline for Treatment of Increased Intracranial Pressure
- ClinicalTrials.gov ID
- NCT00359697
- Acronym / sponsor ID
- 06U.132
- Conditions
- Increased Intracranial Pressure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- First posted
- 2 Aug 2006 (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 overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. The hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol.
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 (5 listed)
- Documented SAH (by computed tomography or lumbar puncture), ICH, TBI or brain tumor
- Patient greater than or equal to 18 years of age
- ICP monitor in place
- ICP greater than 20mmHg, not related to a transient noxious stimulus and not responding to standard measures for controlling ICP (ventricular drainage, elevation of head of the bed and optimizing PaCO2)
- Patient or patient's legally authorized representative has provided written informed consent
Key exclusion criteria (8 listed)
- Patient less than 18 years of age
- Lack of ICP monitoring
- Patient received Mannitol prior to placement of ICP monitor
- Baseline serum osmolarity of greater than 310 mOsm/L
- Patient is currently enrolled in another investigational drug or device study
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 |
|---|---|---|
| Hypertonic Saline, Mannitol | Drug | – |
Primary outcome
Reduction of ICP below treatment threshold (less than 20 mmHg)
1 secondary outcome
Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
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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.
Robert H Rosenwasser, MD principal investigator
Thomas Jefferson University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hypertonic Saline, Mannitol in people with Increased Intracranial Pressure, run by Thomas Jefferson University.
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 5 inclusion and 8 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 6 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
Reduction of ICP below treatment threshold (less than 20 mmHg). 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 2014.