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NCT Number: NCT06646484

Interest of Impedancemetry in Monitoring Hydration and Hyponatremia During Subarachnoid Hemorrhages

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospices Civils de Lyon. Neurological ICU

Lyon, France, 69500

Location status: Recruiting

Location contact

Thomas RITZENTHALER, MD

CONTACT

[email protected]

04.72.11.66.02

Thomas RITZENTHALER, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients under legal protection
  • Pregnancy

Treatment and study plan

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Julien BERTHILLER

CONTACT

[email protected]

04 27 85 63 01

Thomas RITZENTHALER, MD

CONTACT

[email protected]

04.72.11.66.02

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: BIASHA

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 17, 2024
Registry last updated
Jan 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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