Cerebral EdemaEarly Phase 1NCT03330704
Small-Volume, Patient-Specific, Balanced Hypertonic Fluid Protocol Validation
A Early Phase 1 study testing 3% Sodium Chloride, 23.4% Sodium Chloride and 8.4% Sodium Bicarbonate in people with Cerebral Edema and Saline Solution, Hypertonic, run by Stanford University at 1 site in United States.
Trial summary
Many patients with traumatic brain injuries (including strokes, blood clots, or other brain injuries) are given concentrated salt water solutions (hypertonic saline) in order to treat brain swelling (cerebral edema). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Edema, Saline Solution, Hypertonic
- What is being tested?
- 3% Sodium Chloride, 23.4% Sodium Chloride and 8.4% Sodium Bicarbonate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2017to 1 Jan 2020
- Phase
- Early 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
- Able to consent
- 18 years or older
- English speaking
- Clinical indication (intracranial hypertension from cerebral edema) for hypertonic fluid administration
Who cannot join
- Fails to consent
- < 18 years old
- Hypertonic therapy not indicated
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University Hospital
Stanford, California, 94305
About this study
Official title: Randomized Controlled Trial for the Use of Patient Tailored Balanced Hypertonic Solutions in Patients With Cerebral Edema
Many patients with traumatic brain injuries (including strokes, blood clots, or other brain injuries) are given concentrated salt water solutions (hypertonic saline) in order to treat brain swelling (cerebral edema). Current therapies consist of a mixture of sodium and chloride, which can lead to high levels of serum chloride and increased total body water. High levels of chloride can cause acidosis, which can cause the body to function sub-optimally. Therefore, the investigators are proposing to use two concentrated solutions in these patients at the same time that will allow for a lower total volume of solution administration and reduce the rise in chloride to prevent acidosis. The main outcome will therefore be the patients sodium level, chloride level and serum pH.
- Conditions
- Cerebral Edema, Saline Solution, Hypertonic
- Being tested
- 3% Sodium Chloride, 23.4% Sodium Chloride, 8.4% Sodium Bicarbonate
- Medical subject headings
- Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3% Sodium ChlorideDrug
3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
23.4% Sodium ChlorideDrug
23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
8.4% Sodium BicarbonateDrug
8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | Active comparator | This group will receive 3% hypertonic sodium chloride for the management of their cerebral edema. 3% Sodium Chloride is the generic name of this intravenous fluid preparation. Receives: Drug: 3% Sodium Chloride |
| Balanced Therapy | Experimental | This group will undergo two simultaneous infusions. 23.4% sodium chloride and 8.4% sodium bicarbonate will be infused at the same time in various ratios for management of cerebral edema with a balanced approach Receives: Drug: 23.4% Sodium Chloride; Drug: 8.4% Sodium Bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total volume of intravenous hypertonic fluid administered to the patient
Total hypertonic fluid volume administered to each group of patients measured in milliliters of fluid.
Measured: The fluid will be infused until the new serum sodium goal is achieved. This outcome measure will be assessed 1 week after study enrollment
Secondary outcomes (1)
Urine output
Urine output will be collected and measured quantitatively in milliliter units.
Measured: Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start28 Nov 2017
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Why it stopped: lack of eligible study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral EdemaStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Angelotti, Stanford University
- Investigators
- Tim Angelotti, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330704
- Sponsor's protocol ID
- IRB-43653
- Status last verified
- Feb 2019
- First submitted
- 23 Oct 2017
- Last updated
- 19 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data
Publications
Wilcox CS. Regulation of renal blood flow by plasma chloride. J Clin Invest. 1983 Mar;71(3):726-35. doi: 10.1172/jci110820.
PubMed 6826732Toung TJ, Nyquist P, Mirski MA. Effect of hypertonic saline concentration on cerebral and visceral organ water in an uninjured rodent model. Crit Care Med. 2008 Jan;36(1):256-61. doi: 10.1097/01.CCM.0000295306.52783.1E.
PubMed 18090381Diringer MN, Zazulia AR. Osmotic therapy: fact and fiction. Neurocrit Care. 2004;1(2):219-33. doi: 10.1385/NCC:1:2:219.
PubMed 16174920Erdman MJ, Riha H, Bode L, Chang JJ, Jones GM. Predictors of Acute Kidney Injury in Neurocritical Care Patients Receiving Continuous Hypertonic Saline. Neurohospitalist. 2017 Jan;7(1):9-14. doi: 10.1177/1941874416665744. Epub 2016 Aug 29.
PubMed 28042364Neavyn MJ, Boyer EW, Bird SB, Babu KM. Sodium acetate as a replacement for sodium bicarbonate in medical toxicology: a review. J Med Toxicol. 2013 Sep;9(3):250-4. doi: 10.1007/s13181-013-0304-0.
PubMed 23636658
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for the Use of Patient Tailored Balanced Hypertonic Solutions in Patients With Cerebral Edema
- ClinicalTrials.gov ID
- NCT03330704
- Acronym / sponsor ID
- IRB-43653
- Conditions
- Cerebral Edema, Saline Solution, Hypertonic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of eligible study participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 6 Nov 2017 (actual)
- 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.
Many patients with traumatic brain injuries (including strokes, blood clots, or other brain injuries) are given concentrated salt water solutions (hypertonic saline) in order to treat brain swelling (cerebral edema). Current therapies consist of a mixture of sodium and chloride, which can lead to high levels of serum chloride and increased total body water. High levels of chloride can cause acidosis, which can cause the body to function sub-optimally. Therefore, the investigators are proposing to use two concentrated solutions in these patients at the same time that will allow for a lower total volume of solution administration and reduce the rise in chloride to prevent acidosis. The main outcome will therefore be the patients sodium level, chloride level and serum pH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | Active comparator | Drug: 3% Sodium ChlorideThis group will receive 3% hypertonic sodium chloride for the management of their cerebral edema. 3% Sodium Chloride is the generic name of this intravenous fluid preparation. |
| Balanced Therapy | Experimental | Drug: 23.4% Sodium Chloride, Drug: 8.4% Sodium BicarbonateThis group will undergo two simultaneous infusions. 23.4% sodium chloride and 8.4% sodium bicarbonate will be infused at the same time in various ratios for management of cerebral edema with a balanced approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to consent
- 18 years or older
- English speaking
- Clinical indication (intracranial hypertension from cerebral edema) for hypertonic fluid administration
Key exclusion criteria (3 listed)
- Fails to consent
- < 18 years old
- Hypertonic therapy not indicated
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 |
|---|---|---|
| 3% Sodium Chloride3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure | Drug | Standard Therapy |
| 23.4% Sodium Chloride23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure | Drug | Balanced Therapy |
| 8.4% Sodium Bicarbonate8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure | Drug | Balanced Therapy |
Primary outcome
Total volume of intravenous hypertonic fluid administered to the patient
Time frame: The fluid will be infused until the new serum sodium goal is achieved. This outcome measure will be assessed 1 week after study enrollment
Total hypertonic fluid volume administered to each group of patients measured in milliliters of fluid.
1 secondary outcome
Urine output
Time frame: Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2020.
- Background: PubMed 6826732Wilcox CS. Regulation of renal blood flow by plasma chloride. J Clin Invest. 1983 Mar;71(3):726-35. doi: 10.1172/jci110820.
- Background: PubMed 18090381Toung TJ, Nyquist P, Mirski MA. Effect of hypertonic saline concentration on cerebral and visceral organ water in an uninjured rodent model. Crit Care Med. 2008 Jan;36(1):256-61. doi: 10.1097/01.CCM.0000295306.52783.1E.
- Background: PubMed 16174920Diringer MN, Zazulia AR. Osmotic therapy: fact and fiction. Neurocrit Care. 2004;1(2):219-33. doi: 10.1385/NCC:1:2:219.
- Background: PubMed 28042364Erdman MJ, Riha H, Bode L, Chang JJ, Jones GM. Predictors of Acute Kidney Injury in Neurocritical Care Patients Receiving Continuous Hypertonic Saline. Neurohospitalist. 2017 Jan;7(1):9-14. doi: 10.1177/1941874416665744. Epub 2016 Aug 29.
- Background: PubMed 23636658Neavyn MJ, Boyer EW, Bird SB, Babu KM. Sodium acetate as a replacement for sodium bicarbonate in medical toxicology: a review. J Med Toxicol. 2013 Sep;9(3):250-4. doi: 10.1007/s13181-013-0304-0.
- Individual participant dataSharing planned: No. No plan to share data
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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.
Tim Angelotti, MD, PhD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 3% Sodium Chloride, 23.4% Sodium Chloride and 8.4% Sodium Bicarbonate in people with Cerebral Edema and Saline Solution, Hypertonic, run by Stanford University 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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 19 Mar 2020. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was withdrawn before enrolling participants, so there are no results.
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?
Total volume of intravenous hypertonic fluid administered to the patient (time frame: The fluid will be infused until the new serum sodium goal is achieved. This outcome measure will be assessed 1 week after study enrollment). 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 NCT03330704, which also lists 5 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 19 Mar 2020.