Interest of Impedancemetry in Monitoring Hydration and Hyponatremia During Subarachnoid Hemorrhages

NCT06646484 | Recruiting

• 2 other identifiers: 69HCL24_07832024-A02117-40
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Keywords

subarachnoid hemorrhage; impedancemetry; hydration

Outcome Measures

Primary Outcomes (1)

• 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.

  Every 48 hours during the mean 21 days of stay in the neurological ICU.

Study Arms (1)

Patients hospitalized due to subarachnoid hemorrhages

Each patient eligible for the study hospitalized due to subarachnoid hemorrhages

Diagnostic Test: Impedancemetry evaluation

Interventions

Impedancemetry evaluation DIAGNOSTIC_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.

Patients hospitalized due to subarachnoid hemorrhages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in the neurological ICU of Louis Pradel Hospital Lyon in the 72h post subarachnoid hemorrhage.

You may qualify if:

• 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

You may not qualify if:

• Patients under legal protection
• Pregnancy

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon. Neurological ICU

Lyon, France, 69500, France

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thomas RITZENTHALER, MD

CONTACT

04.72.11.66.02; Thomas.ritzenthaler@chu-lyon.fr

Julien BERTHILLER

CONTACT

04 27 85 63 01; Julien.berthiller@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 17, 2024
• Study Start: December 30, 2024
• Primary Completion: December 30, 2025
• Study Completion: January 21, 2026
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)