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Not yet recruiting NCT06590688

Defining Volume Status with Extracellular Water Measurement in Patients with Intracranial Hemorrhage

Observational Intracranial Hemorrhages

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intracranial Hemorrhages. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Extracellular Water for Volume Status Characterization in Patients with Intracranial Hemorrhage

Overview

The goal of this observational study is to learn about the influence of extracellular water on volume status in adult patients with intracranial hemorrhage presenting with hemodynamic instability. The main question it aims to answer is: • Can measurement of extracellular water contribute to the description of hemodynamic instability in adult patients with intracranial hemorrhage. Patients with intracranial hemorrhage admitted to intensive care will receive standard care with the addition of measurement of extracellular water.

Detailed description

Adult patients with intracranial hemorrhage admitted to ICU will be recruited. During the first five days after inclusion blood samples and extended non-invasive monitoring, including monitoring of the microcirculation (CytoCam) and measurement of extracellular water (dielectronic constant), will be added to routine care and monitoring.

Primary outcome measures

  • Extracellular water for volume status characterization in patients with intracranial hemorrhage. [Time frame: 7 days]

Eligibility criteria

Inclusion criteria

  • Adults with intracranial hemorrhage admitted to ICU.

Exclusion criteria

  • Pregnancy, palliative care.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Nuutinen J, Ikaheimo R, Lahtinen T. Validation of a new dielectric device to assess changes of tissue water in skin and subcutaneous fat. Physiol Meas. 2004 Apr;25(2):447-54. doi: 10.1088/0967-3334/25/2/004. PMID 15132310
  • Toro C, Markarian B, Mayrovitz HN. Breast Cancer-Related Lymphedema Assessed via Tissue Dielectric Constant Measurements. Cureus. 2024 Apr 29;16(4):e59261. doi: 10.7759/cureus.59261. eCollection 2024 Apr. PMID 38813316
  • Gress DR; Participants in the International Multi-Disciplinary Consensus Conference on the Critical Care Management of Subarachnoid Hemorrhage. Monitoring of volume status after subarachnoid hemorrhage. Neurocrit Care. 2011 Sep;15(2):270-4. doi: 10.1007/s12028-011-9604-x. PMID 21751101

Identifiers

NCT: NCT06590688 · 2023-06866-01.3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗