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Patient-reported Outcome After Status Epilepticus

NCT05491590 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 66

Last updated 2024-11-26

No results posted yet for this study

Summary

Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments.

The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied.

Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term post-resuscitation syndrome (PICS), neuronal lesions consecutive to the SE itself or to its cause could be responsible for these different functional alterations. Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress.

Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. Here, we propose the development of a cross-sectional collection of PROs of the different constituents of PICs and HR-QOLs, and associated with functional patient outcomes, in those who required ICU management for status epilepticus.

Conditions

  • Patient Reported Outcomes
  • Long Term Outcomes
  • Status Epilepticus
  • Intensive Care Unit
  • Intensive Care Unit Syndrome

Sponsors & Collaborators

  • Versailles Hospital

    lead OTHER

Principal Investigators

  • Gwenaelle JACQ, RN,MSc,PhDc · Versailles Hospital

  • Stephane LEGRIEL, MD,PhD · Versailles Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-15
Primary Completion
2024-06-10
Completion
2024-06-10

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05491590 on ClinicalTrials.gov