Subarachnoid HemorrhageION_SAHNCT05942755
Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage
An observational study of Subarachnoid Hemorrhage, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- 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.
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2022to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SAH group : patients hospitalized in the neurological intensive care with Fisher modified aneurysmal SAH 3 or 4 requiring external ventricular drain. Control group : patients hospitalized for normal pressure hydrocephalus
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Femme Mère Enfant
Bron, 69500
Baptiste BALANCA, MD, PhD, 04 72 35 75 76 ext. +33, baptiste.balanca@chu-lyon.fr
Baptiste BALANCA, MD, PhD
About this study
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.
Read more
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.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- 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.
- Keywords
- subarachnoid haemorrhage, cerebrospinal fluid, ionic disorders, hyponatremia, normal pressure hydrocephalus, blood-brain barrier, ionogram
- Medical subject headings
- Subarachnoid Hemorrhage, Hyponatremia, Hydrocephalus, Normal Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.Other
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. | |
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the change in CSF ionogram between day 0 and day 14 according to the occurrence of hyponatremia.
Measured: The patient is included during hospitalization within 2 days of the placement of the EVD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Oct 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942755
- Sponsor's protocol ID
- 69HCL23_0245
- Acronym
- ION_SAH
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Changes in CSF Ionic Composition After Aneurysmal Meningeal Hemorrhage
- ClinicalTrials.gov ID
- NCT05942755
- Acronym / sponsor ID
- ION_SAH / 69HCL23_0245
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- subarachnoid haemorrhage, cerebrospinal fluid, ionic disorders, hyponatremia, normal pressure hydrocephalus, blood-brain barrier, ionogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subarachnoid haemorrhage with Fisher 3 or 4. | – | 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.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. |
| Control group, normal pressure hydrocephalus | – | 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.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SAH group : patients hospitalized in the neurological intensive care with Fisher modified aneurysmal SAH 3 or 4 requiring external ventricular drain. Control group : patients hospitalized for normal pressure hydrocephalus
Key inclusion criteria (7 listed)
- 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.
- Adults
- Performing a perfusion test in the operating room for normal pressure hydrocephalus
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Control group, normal pressure hydrocephalus, Subarachnoid haemorrhage with Fisher 3 or 4. |
Primary outcome
The primary endpoint will be the change in CSF ionogram between day 0 and day 14 according to the occurrence of hyponatremia.
Time frame: The patient is included during hospitalization within 2 days of the placement of the EVD
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be the change in CSF ionogram between day 0 and day 14 according to the occurrence of hyponatremia. (time frame: The patient is included during hospitalization within 2 days of the placement of the EVD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.