Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage (NCT05942755) | Clinical Trial Compass
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Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage
France80 participantsStarted 2022-10-01
Plain-language summary
Hyponatremia is a frequent complication of subarachnoid hemorrhage (SAH) with a prevalence of 30 to 50% in patients with this condition. This hydro-electrolytic disorder is responsible for an increase in morbidity with the appearance of neurological disorders.
Also, it has been shown that there are ionic changes in the cerebrospinal fluid and a probable alteration of the blood-brain barrier in patients with SAH. The kinetics and relationship between hyponatremia and these changes remain unknown.
The main objective of the study is to determine whether the change in cerebrospinal fluid (CSF) composition, precedes the development of hyponatremia. For this, the investigators propose to study the evolution of the CSF ionogram with the blood ionogram. Furthermore, they will perform additional analyses on the basis of a control group (CSF of patient with normal pressure hydrocephalus) to determine the effect of SAH on ionic changes.
The hypothesis of the study is that there is a correlation between the change in CSF blood ionogram and the development of hyponatremia between day 0 and day 14.
Who can participate
Age range
18 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:
SAH group :
* Adults
* Hospitalized in the neurological intensive care unit for a Fisher modified aneurysmal SAH 3 or 4 with EVD and urinary catheter.
* With a catheter (arterial or venous) for repeated sampling.
Control group :
* Adults
* Performing a perfusion test in the operating room for normal pressure hydrocephalus
Exclusion Criteria:
* Patients with SAH without EVD.
* Patients with non-aneurysmal SAH.
* Pregnant or breastfeeding women.
* Patients under legal protection, guardianship, curatorship, safeguard of justice.
* Patients participating in a study that may interfere with the present study.
* Persons under forced psychiatric care.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
What they're measuring
1
The primary endpoint will be the change in CSF ionogram between day 0 and day 14 according to the occurrence of hyponatremia.
Timeframe: The patient is included during hospitalization within 2 days of the placement of the EVD