Examining changes in cerebrospinal fluid after a brain hemorrhage
Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage
This study looks at how the fluid around the brain changes in people who have had a brain bleed to see if these changes can help predict a common problem called low sodium levels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Bron) |
| Trial ID | NCT05942755 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the ionic composition of cerebrospinal fluid (CSF) in patients who have experienced a subarachnoid hemorrhage (SAH). It aims to determine whether changes in CSF composition occur before the onset of hyponatremia, a common complication in these patients. By concurrently evaluating blood and CSF ionograms over a period of 14 days, the study will compare findings from SAH patients with a control group of individuals undergoing tests for normal pressure hydrocephalus. The goal is to better understand the relationship between ionic changes in CSF and the development of hyponatremia.
Who should consider this trial
Good fit: Ideal candidates include adults hospitalized in a neurological intensive care unit for Fisher modified aneurysmal SAH with an external ventricular drain.
Not a fit: Patients with non-aneurysmal SAH or those without an external ventricular drain will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of hyponatremia in patients with subarachnoid hemorrhage, potentially reducing morbidity.
How similar studies have performed: While there is existing literature on hyponatremia in SAH, this specific approach to studying CSF ionic changes is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bron
- Hopital Femme Mère Enfant — Bron, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.