Patient-reported Outcome After Status Epilepticus

NCT ID: NCT05491590

Last Updated: 2024-11-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 66 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-15
• Study Completion Date: 2024-06-10

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Adults 18 years old or older
• Patients previously included in the ICTAL registry (Status Epilepticus cohort NCT03457831)
• Survivors after ICU management for Status Epilepticus More than 3 months and less than 5 years after ICU discharge

Exclusion Criteria

• Legal guardianship
• Opposition to participate
• Unread and unwritten French language
• Patient not affiliated to a Social Security system

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versailles Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jacq Gwenaelle

Investigator Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gwenaelle JACQ, RN,MSc,PhDc

Role: PRINCIPAL_INVESTIGATOR

Versailles Hospital

Stephane LEGRIEL, MD,PhD

Role: STUDY_DIRECTOR

Versailles Hospital

Locations

CHVersailles

Le Chesnay, Yvelines, France

CH de Bethune

Beuvry, , France

CHU de Brest

Brest, , France

CH de Brive la Gaillarde

Brive-la-Gaillarde, , France

CH de Cannes

Cannes, , France

CH du Cotentin

Cherbourg, , France

CHU de Beaujon

Clichy, , France

CHU Henri Mondor

Créteil, , France

CHU de Dijon

Dijon, , France

CH de la Rochelle

La Rochelle, , France

GH Sud Ile de France

Melun, , France

CHU de Nantes

Nantes, , France

GH Paris Saint Joseph

Paris, , France

Hôpital Claude Galien

Quincy-sous-Sénart, , France

CH de Roanne

Roanne, , France

CH de Toulon-La Seyne sur Mer

Toulon, , France

Countries

France

Other Identifiers

P21/11 - POSEIDON

Identifier Type: -

Identifier Source: org_study_id