Early Induced Hypernatremia for the Prevention and Management of Brain Edema (NCT02798601) | Clinical Trial Compass
WithdrawnNot Applicable
Early Induced Hypernatremia for the Prevention and Management of Brain Edema
Stopped: Lack of funds
0Started 2017-01-18
Plain-language summary
The purpose of this study is to estimate the effect of an early induced hypernatremia protocol (150-155 milliequivalent/L) versus normonatremia plus mannitol (135 - 145 milliequivalent/L) in terms of neurologic outcome in patients with severe traumatic brain injury managed at critical care unit.
Who can participate
Age range
14 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient greater than 14 years old, who suffered severe non-penetrating Brain Trauma (Glasgow Coma Scale (GCS) equal or less than 8) and a motor GCS equal or less than 5.
. Criteria time: admitted to the Hospital in the first 24 hours of the Brain Trauma (BT) and admitted to ICU in the first 48 hours of brain trauma.
. Tomographic evidence of brain edema (one of the following criteria: deviation from the midline, obliteration of perimesencephalic cistern or altered cortico-subcortical differentiation).
Exclusion criteria
. Patient with GCS 3 and bilateral mydriatic pupils and unreactive to light, in the presence of hemodynamic stability (systolic blood pressure equal or greater than 90 mmHg).
. Patient with insipid diabetes at the ICU admission.
. Patient with limitation of therapeutic effort.
. Non-neurological Abbreviated Injury Score greater than 3.
. Patient past medical history of kidney failure, liver disease or heart failure.
. Serum sodium less than 135 or greater than 150 milliequivalent/L.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial on early induced hypernatremia for brain edema after head trauma has been withdrawn before enrolling anyone, can you tell me why it was withdrawn and whether that affects how we should think about this approach for my situation?
2Given that this study was testing a strategy of deliberately raising sodium levels in the blood to manage brain swelling after head trauma, what are the known risks of induced hypernatremia, and are there currently accepted alternatives you'd recommend instead?
3The trial was planning to measure outcomes using the Glasgow Outcome Scale Extended — can you explain what that scale measures, and how it relates to the kind of recovery I or my loved one might expect with current standard treatments?
4Because this trial never got off the ground, is there any other active or completed research on early sodium-based therapies for post-traumatic brain edema that might be more relevant for us to discuss?
5Since this was listed as Phase NA, meaning it may have been a very early or pilot-stage study, what does that tell us about how much was already known about the safety and effectiveness of this approach before it was withdrawn?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.