An Early Phase 1 interventional study of 3% Sodium Chloride and 23.4% Sodium Chloride in Cerebral Edema and Saline Solution, Hypertonic, sponsored by Stanford University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by Stanford University · Early Phase 1, Interventional, and Treatment
Among 34 studies in Brain Edema with a site in United States — 5 open to participants now, 7 under way, none of them phase 3. Brain Edema · United States.
Among the 34 studies in Brain Edema with a site in United States, this one is the 29th largest by enrollment of the 31 interventional ones, is one of 5 that started in 2017, is one of 4 in phase 1, and was the 25th registered.
102 studies on the registry are indexed under Brain Edema; 25 are open to participants now.
Browse Brain Edema studies →5 of the 34 studies in Brain Edema with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 10 Brain Edema studies recruiting now, 2 (20%) set no upper age limit and 2 (20%) stop at 75 or younger; 1 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →34 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 5 started in 2017.
Median enrollment 41 across the 31 interventional studies, 100 across the 3 observational. Of the 23 that completed or were terminated, 13 (57%) have results posted.
6 of 34 have an industry lead sponsor. The 10 most frequent:
Stanford University is the lead sponsor of 2,168 studies on the registry; 431 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 207 (78%) have results posted.
Stanford University has 1 study filed under Brain Edema — fewer than ten, so there is no comparison to draw.
2 of the studies in Brain Edema with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05020535Johns Hopkins UniversityBiomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) | 2026-11-30 |
| NCT07510074The University of Texas Health Science Center at San AntonioModulating Inflammation in Neuro-Trauma | 2027-07 |
Among the 34 studies in Brain Edema with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Drug: 3% Sodium Chloride
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
Drug: 23.4% Sodium Chloride · Drug: 8.4% Sodium Bicarbonate
3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure
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.
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
Urine output
Urine output will be collected and measured quantitatively in milliliter units.
Time frame: Urine output during active hypertonic fluid infusion will be measured. This outcome measure will be assessed 1 week after study enrollment
Plan to share: No — No plan to share data
Ran from Nov 2017 to primary completion in Jan 2020, 25 months.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sodium Chloride · Sodium Bicarbonate