Severe Traumatic Brain InjuryPhase 1NCT00930202
Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury
A Phase 1 study testing Conivaptan (Vaprisol) in people with Severe Traumatic Brain Injury, run by University of Washington at 1 site in United States.
Trial summary
The investigators plan to utilize conivaptan (Vaprisol) to promote isolated water loss, in combination with normal (physiologic) fluid replacement to maintain a normal blood volume status, in patients with severe TBI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Traumatic Brain Injury
- What is being tested?
- Conivaptan (Vaprisol)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jun 2010
- 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
- 18 years old or greater
- Initial diagnosis of an isolated, severe traumatic brain injury (Glasgow Coma Score of 8 or less upon initial evaluation)
- Cerebral edema with a head CT and Marshall classification of diffuse injury type II, III, or IV.
- Primary care team orders to raise blood sodium by 10 mEq/L from baseline.
- Placement of an intraparenchymal fiberoptic monitor to monitor intracranial pressure (ICP).
Who cannot join
- Age < 18 years
- Signs of hypovolemia including systolic BP < 90 mmHg
- Signs of liver disease including jaundice and ascites
- AST > 35 units/L
- ALT > 35 units/L
- Signs of renal disease including history of dialysis
Show all 15Show fewer
- Serum creatinine > 1.5 mg/dL
- BUN > 20 mg/dL range
- Baseline serum sodium >/= 145 mEq/L
- Pregnant or lactating females
- Concomitant use of digoxin, ketoconazole, itraconazole, clarithromycin, ritonavir, indinavir, simvastatin and lovastatin
- Presentation to the tertiary care hospital > 24 hours post-injury
- Multi-system traumatic injuries
- Diabetes Insipidus
- Anticipation of diagnosis compatible with brain death, or no expectation of survival with 48 hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Open Label Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury
The investigators plan to utilize conivaptan (Vaprisol) to promote isolated water loss, in combination with normal (physiologic) fluid replacement to maintain a normal blood volume status, in patients with severe TBI. The goal of this therapy is to raise blood sodium in a controlled fashion in subjects with severe TBI, and reduce the use of hypertonic saline infusion. We hypothesize that this therapy will maintain a stable state of high blood sodium, while decreasing the overall sodium load needed to achieve these goals.
- Conditions
- Severe Traumatic Brain Injury
- Being tested
- Conivaptan (Vaprisol)
- Keywords
- Traumatic Brain Injury, Conivaptan, Vaprisol, Sodium
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conivaptan (Vaprisol)Drug
Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Conivaptan (Vaprisol) | Experimental | Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes. Receives: Drug: Conivaptan (Vaprisol) |
| Standard Care | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of events of excessive rate of increase in sodium levels (>1 mEq/hr).
Measured: Every 4 hours
Secondary outcomes (5)
Safety profile: number of events of increased serum sodium levels above the intended target range, and any adverse events occurring during the study period.
Measured: Hospital Stay
Sodium load: Sodium load is defined as the cumulative amount of sodium administered by enteral and parenteral routes from the time of randomization to 48 hours post-randomization
Measured: Until 48 hours post randomization
Serum sodium stability: a. Stable state of hypernatremia b. Sodium variability c. Time to achievement of target sodium levels after randomization
Measured: Until 48 hours post randomization
Fluid balance
Measured: Until 48 hours post randomization
Cerebral edema: a. Mean ICP in the first 48 hours after randomization b. Reduction of cerebral edema
Measured: Until 48 hours post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- Miriam Treggiari, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930202
- Sponsor's protocol ID
- 35774-A
- Status last verified
- Sep 2010
- First submitted
- 26 Jun 2009
- Last updated
- 10 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study of the Safety and Efficacy of Conivaptan (Vaprisol®) to Raise Serum Sodium Levels in Patients With Severe Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00930202
- Acronym / sponsor ID
- 35774-A
- Conditions
- Severe Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury, Conivaptan, Vaprisol, Sodium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 30 Jun 2009 (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 investigators plan to utilize conivaptan (Vaprisol) to promote isolated water loss, in combination with normal (physiologic) fluid replacement to maintain a normal blood volume status, in patients with severe TBI. The goal of this therapy is to raise blood sodium in a controlled fashion in subjects with severe TBI, and reduce the use of hypertonic saline infusion. We hypothesize that this therapy will maintain a stable state of high blood sodium, while decreasing the overall sodium load needed to achieve these goals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conivaptan (Vaprisol) | Experimental | Drug: Conivaptan (Vaprisol)Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes. |
| Standard Care | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years old or greater
- Initial diagnosis of an isolated, severe traumatic brain injury (Glasgow Coma Score of 8 or less upon initial evaluation)
- Cerebral edema with a head CT and Marshall classification of diffuse injury type II, III, or IV.
- Primary care team orders to raise blood sodium by 10 mEq/L from baseline.
- Placement of an intraparenchymal fiberoptic monitor to monitor intracranial pressure (ICP).
Key exclusion criteria (15 listed)
- Age < 18 years
- Signs of hypovolemia including systolic BP < 90 mmHg
- Signs of liver disease including jaundice and ascites
- Signs of renal disease including history of dialysis
- Baseline serum sodium >/= 145 mEq/L
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 |
|---|---|---|
| Conivaptan (Vaprisol)Conivaptan (Vaprisol) will be administered in a single dose of 20 mg, mixed with 100 mL of 5% dextrose in water, and delivered over 30 minutes. | Drug | Conivaptan (Vaprisol) |
Primary outcome
Number of events of excessive rate of increase in sodium levels (>1 mEq/hr).
Time frame: Every 4 hours
5 secondary outcomes
Safety profile: number of events of increased serum sodium levels above the intended target range, and any adverse events occurring during the study period.
Time frame: Hospital Stay
Sodium load: Sodium load is defined as the cumulative amount of sodium administered by enteral and parenteral routes from the time of randomization to 48 hours post-randomization
Time frame: Until 48 hours post randomization
Serum sodium stability: a. Stable state of hypernatremia b. Sodium variability c. Time to achievement of target sodium levels after randomization
Time frame: Until 48 hours post randomization
Fluid balance
Time frame: Until 48 hours post randomization
Cerebral edema: a. Mean ICP in the first 48 hours after randomization b. Reduction of cerebral edema
Time frame: Until 48 hours post randomization
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 10 Sep 2010.
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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.
Miriam Treggiari, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Conivaptan (Vaprisol) in people with Severe Traumatic Brain Injury, run by University of Washington at 1 site in United States.
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 15 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 10 Sep 2010. 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 United States. 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 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?
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?
Number of events of excessive rate of increase in sodium levels (>1 mEq/hr). (time frame: Every 4 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 10 Sep 2010.