Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage

Recruiting

• Conditions: Subarachnoid Hemorrhage

• Registration Number: NCT05942755
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-04
• Study First Submitted QC: 2023-07-04
• Last Update Submitted: 2023-07-04
• Study First Posted: 2023-07-12
• Last Update Posted: 2023-07-12
• Primary Completion: 2023-11-01
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be the change in CSF ionogram between day 0 and day 14 according to the occurrence of hyponatremia.	The patient is included during hospitalization within 2 days of the placement of the EVD

Trial Locations

Locations (1)

Hopital Femme Mère Enfant; 🇫🇷 Bron, France