Subarachnoid Hemorrhage (SAH)BIASHANCT06646484
Interest of Impedancemetry in Monitoring Hydration and Hyponatremia During Subarachnoid Hemorrhages
An observational study of Subarachnoid Hemorrhage (SAH), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Subarachnoid hemorrhage (SAH) is a rare and serious form of stroke, mainly linked to the rupture of an intracranial aneurysm responsible for bleeding into the meningeal spaces. The main late serious complication is delayed cerebral ischemia (DCI), resulting in the appearance of new neurological deficits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage (SAH)
- What is being tested?
- Impedancemetry evaluation
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Dec 2024to 21 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients hospitalized in the neurological ICU of Louis Pradel Hospital Lyon in the 72h post subarachnoid hemorrhage.
Who may be able to join
- Adult man, woman
- Hospitalized following Subarachnoid Hemorrhage within 72 hours of bleeding
- Admitted to the neurological intensive care unit for less than 48 hours
- Being able to understand the ins and outs of the study
- Having expressed his non-opposition
Who cannot join
- Patients under legal protection
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon. Neurological ICU
Lyon, France, 69500
Thomas RITZENTHALER, MD, 04.72.11.66.02, Thomas.ritzenthaler@chu-lyon.fr
Thomas RITZENTHALER, MD
About this study
Subarachnoid hemorrhage (SAH) is a rare and serious form of stroke, mainly linked to the rupture of an intracranial aneurysm responsible for bleeding into the meningeal spaces.
The main late serious complication is delayed cerebral ischemia (DCI), resulting in the appearance of new neurological deficits.
Read more
Prevention of ICR involves in particular maintaining euvolemia, and early treatment of hyponatremia, itself dependent on the level of volume.
Evaluation of water status and sodium balance is therefore essential. This assessment is complicated and relies on indirect parameters, both clinical and biological.
Impedancemetry, making it possible to measure water volumes and sodium load, could be an aid in the management of blood volume and sodium intake.
- Conditions
- Subarachnoid Hemorrhage (SAH)
- Being tested
- Impedancemetry evaluation
- Keywords
- subarachnoid hemorrhage, impedancemetry, hydration
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impedancemetry evaluationDiagnostic test
Each patient eligible for the study will, additionally to the standard care, have repeated measure of impedancemetry along their hospital stay ; Theses measure will be compared to the usual measure of hydration and natremia and agreement between clinical status of interest will be discussed.
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalized due to subarachnoid hemorrhages | Each patient eligible for the study hospitalized due to subarachnoid hemorrhages Receives: Diagnostic Test: Impedancemetry evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydration measurements
The level of hydration is quantified by the indicator "Hydration of non-fat mass in%" using the impedancemetry. Threshold values for hydration indices are specific to the measurement performed on the patient and depend on their age, gender and body composition data.
Measured: Every 48 hours during the mean 21 days of stay in the neurological ICU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start30 Dec 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion21 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Hemorrhage (SAH)Studies 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
- 100 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
- NCT06646484
- Sponsor's protocol ID
- 69HCL24_0783
- Other IDs
- 2024-A02117-40
- Acronym
- BIASHA
- Status last verified
- Jan 2025
- First submitted
- 11 Oct 2024
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Impedancemetry in Monitoring Hydration and Hyponatremia During Subarachnoid Hemorrhages
- ClinicalTrials.gov ID
- NCT06646484
- Acronym / sponsor ID
- BIASHA / 69HCL24_0783
- Conditions
- Subarachnoid Hemorrhage (SAH)
- Keywords
- subarachnoid hemorrhage, impedancemetry, hydration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 21 Jan 2026 (estimated)
- First posted
- 17 Oct 2024 (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.
Subarachnoid hemorrhage (SAH) is a rare and serious form of stroke, mainly linked to the rupture of an intracranial aneurysm responsible for bleeding into the meningeal spaces.
The main late serious complication is delayed cerebral ischemia (DCI), resulting in the appearance of new neurological deficits.
Prevention of ICR involves in particular maintaining euvolemia, and early treatment of hyponatremia, itself dependent on the level of volume.
Evaluation of water status and sodium balance is therefore essential. This assessment is complicated and relies on indirect parameters, both clinical and biological.
Impedancemetry, making it possible to measure water volumes and sodium load, could be an aid in the management of blood volume and sodium intake.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized due to subarachnoid hemorrhages | – | Diagnostic Test: Impedancemetry evaluationEach patient eligible for the study hospitalized due to subarachnoid hemorrhages |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized in the neurological ICU of Louis Pradel Hospital Lyon in the 72h post subarachnoid hemorrhage.
Key inclusion criteria (5 listed)
- Adult man, woman
- Hospitalized following Subarachnoid Hemorrhage within 72 hours of bleeding
- Admitted to the neurological intensive care unit for less than 48 hours
- Being able to understand the ins and outs of the study
- Having expressed his non-opposition
Key exclusion criteria (2 listed)
- Patients under legal protection
- Pregnancy
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 |
|---|---|---|
| Impedancemetry evaluationEach patient eligible for the study will, additionally to the standard care, have repeated measure of impedancemetry along their hospital stay ; Theses measure will be compared to the usual measure of hydration and natremia and agreement between clinical status of interest will be discussed. | Diagnostic test | Patients hospitalized due to subarachnoid hemorrhages |
Primary outcome
Hydration measurements
Time frame: Every 48 hours during the mean 21 days of stay in the neurological ICU.
The level of hydration is quantified by the indicator "Hydration of non-fat mass in%" using the impedancemetry. Threshold values for hydration indices are specific to the measurement performed on the patient and depend on their age, gender and body composition data.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Individual participant dataSharing planned: No
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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.
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 (SAH), 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas RITZENTHALER, MD (04.72.11.66.02, Thomas.ritzenthaler@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydration measurements (time frame: Every 48 hours during the mean 21 days of stay in the neurological ICU.). 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 13 Jan 2025.