Patient-reported Outcome After Status Epilepticus

NCT05491590 | Completed

• 1 other identifier: P21/11 - POSEIDON
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 16

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

Outcome Measures

Primary Outcomes (1)

• percentage of global impairment of HRQoL defined by one and/or other of the physical and mental impairments (after dichotomization of the SF 36 summary scores compared to the general population) in patients managed in the ICU for or with SE.

  36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score\[0-100\], a high score indicate better health status.

  one day

Secondary Outcomes (8)

• percentage of cognitive/physical and/or mental health impairment defined after dichotomization of i)T-MoCA ,ii) GOS, iii)IADL&ADL, iv)HAD, v)IES-r in patients managed in the ICU for or with SE

  one day

• percentage of impairement of HRQoL, in 8 dimensions of the generalist of SF 36, and scores in the 7 dimensions of the specific QOLIE 31 in patients managed in intensive care for or with SE.

  one day

• percentage of impairement of HRQoL, in 8 dimensions of the generalist of SF 36, and scores in the 7 dimensions of the specific QOLIE 31in the SE sub-groups defining (with or without predominant motor signs)

  one day

• Presence or absence Post-ICU factors associed to the PICs, as defined above in patients managed in the ICU for or with SE.

  one day

• Presence or absence of the elements associated with the PICs, as defined above, in the subgroups defining SE (SE with orwithout predominant motor signs,).

  one day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who meet the eligibility criteria will be offered participation in the study.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Versailles Hospital: lead

Study Sites (16)

CHVersailles

Le Chesnay, Yvelines, 78150, France

Location

CH de Bethune

Beuvry, 62660, France

Location

CHU de Brest

Brest, 29200, France

Location

CH de Brive la Gaillarde

Brive-la-Gaillarde, 19100, France

Location

CH de Cannes

Cannes, 06414, France

Location

CH du Cotentin

Cherbourg, 50102, France

Location

CHU de Beaujon

Clichy, 92110, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

CHU de Dijon

Dijon, 21079, France

Location

CH de la Rochelle

La Rochelle, 17019, France

Location

GH Sud Ile de France

Melun, 77000, France

Location

CHU de Nantes

Nantes, 44093, France

Location

GH Paris Saint Joseph

Paris, 75014, France

Location

Hôpital Claude Galien

Quincy-sous-Sénart, 91480, France

Location

CH de Roanne

Roanne, 42328, France

Location

CH de Toulon-La Seyne sur Mer

Toulon, 83056, France

Location

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gwenaelle JACQ, RN,MSc,PhDc

  Versailles Hospital

  PRINCIPAL INVESTIGATOR

• Stephane LEGRIEL, MD,PhD

  Versailles Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Coordinator

Study Record Dates

• First Submitted: August 1, 2022
• First Posted: August 8, 2022
• Study Start: November 15, 2022
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

FR (16)