Interest of Impedancemetry in Monitoring Hydration and Hyponatremia During Subarachnoid Hemorrhages (BIASHA)

January 10, 2025 updated by: Hospices Civils de Lyon

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Lyon, France, 69500
        • Recruiting
        • Hospices Civils de Lyon. Neurological ICU
        • Contact:
        • Contact:
          • Thomas RITZENTHALER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients hospitalized due to subarachnoid hemorrhages
Each patient eligible for the study hospitalized due to subarachnoid hemorrhages
Diagnostic test: Impedancemetry evaluation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Every 48 hours during the mean 21 days of stay in the neurological ICU.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2024

Primary Completion (Estimated)

December 30, 2025

Study Completion (Estimated)

January 21, 2026

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

October 16, 2024

First Posted (Actual)

October 17, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL24_0783
  • 2024-A02117-40 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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