Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage

Subarachnoid Hemorrhage Clinical Trial

— ION_SAH  

Official title:

Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942755
• Other study ID #: 69HCL23_0245
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: July 30, 2024

Study information

• Verified date: July 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 30, 2024
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Other:
• Concurrent evaluation of blood and CSF ionograms to determine if there is a correlation between CSF change and the development of hyoponatremia between day 0 and day 14.
Blood samples are taken as part of routine care on arrival of patients and then every 24 hours if an arterial catheter is in place; otherwise, every Monday, Wednesday and Friday. Samples from the EVD will be taken on Day 0 and then every 24 hours. A urine ionogram is also performed every 24 hours as part of the usual management to regulate water, sodium and potassium intake by enteral or parenteral routine. The ionic composition of CSF from patients with SAH will be compared with a control population of patients hospitalized with normal pressure hydrocephalus. A lumbar puncture is performed in the operating room to evacuate the chronic CSF effusion in the ventricles (hydrocephalus), before performing an intrathecal perfusion test. 1ml of the CSF thus collected will be analyzed to determine its ionic composition

Locations

Country	Name	City	State
France	Hopital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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