ION_SAH: Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Recruiting

CT.gov ID

NCT05942755

Collaborator

(none)

Enrollment

Location

21.9

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subarachnoid Hemorrhage	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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Subarachnoid haemorrhage with Fisher 3 or 4. HAS Group : Adults Hospitalized in the neurological intensive care unit for a Fisher 3 or 4 aneurysmal meningeal hemorrhage with external ventricular drain (EVD) and urinary catheter. This EVD allows the evacuation of 10-20ml/h of CSF into an external collector. CSF is usually removed daily. With a catheter (arterial or venous) for repeated sampling. 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 route. In addition, clinical data will be collected every 24 hours on the basis of a computerized medical record without additional examination.	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
Control group, normal pressure hydrocephalus Control group : Adults Performing a perfusion test in the operating room in the context of 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 the ionic composition and thus compare it to the CSF collected from patients with SAH.	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

Arm

Intervention/Treatment

Subarachnoid haemorrhage with Fisher 3 or 4.

HAS Group : Adults Hospitalized in the neurological intensive care unit for a Fisher 3 or 4 aneurysmal meningeal hemorrhage with external ventricular drain (EVD) and urinary catheter. This EVD allows the evacuation of 10-20ml/h of CSF into an external collector. CSF is usually removed daily. With a catheter (arterial or venous) for repeated sampling. 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 route. In addition, clinical data will be collected every 24 hours on the basis of a computerized medical record without additional examination.

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

Control group, normal pressure hydrocephalus

Control group : Adults Performing a perfusion test in the operating room in the context of 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 the ionic composition and thus compare it to the CSF collected from patients with SAH.

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.