NCT06100978

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 postresuscitation syndrome (PICS), neuronal lesions consecutive to the SE itselfor 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. The POSEIDON study was a cross-sectional collection of PROs and HR-QOL components, and associated with patient functional outcomes, in those who required ICU management for status epilepticus. We propose here to continue the description of potential alterations after a subsequent ME, namely a longitudinal study (POSEIDON 2) which will also include the evaluation of patient-reported experience (PREMS) and the measurement of family burden.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
May 2024Mar 2027

First Submitted

Initial submission to the registry

October 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

May 25, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2027

Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

2.8 years

First QC Date

October 15, 2023

Last Update Submit

July 3, 2026

Conditions

Patient Reported OutcomesPatient SatisfactionLong Term OutcomesStatus EpilepticusIntensive Care UnitBurdenRelatives

Outcome Measures

Primary Outcomes (1)

  • percentage of global impairment of HRQoL

    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.

    at 3 month and 12 month

Secondary Outcomes (9)

  • percentage of cognitive impairment in patients managed in the ICU for or with SE

    at 3 month and 12 month

  • percentage of disability in patients managed in the ICU for or with SE

    at 3 month and 12 month

  • percentage of physical dependency in patients managed in the ICU for or with SE

    at 3 month and 12 month

  • percentage of anxiety and depression in patients managed in the ICU for or with SE

    at 3 month and 12 month

  • percentage of post traumatic syndrome disorder in patients managed in the ICU for or with SE

    at 3 month and 12 month

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

CH d'Angoulême

Angoulême, France

RECRUITING

CH d'Arras

Arras, France

NOT YET RECRUITING

CHU de Besançon

Besançon, France

ACTIVE NOT RECRUITING

CH de Béthune

Béthune, France

RECRUITING

CHU de Brest

Brest, France

RECRUITING

CH de Cannes

Cannes, France

RECRUITING

Hôpital Beaujon

Clichy, France

RECRUITING

Hôpital Henri Mondor

Créteil, France

RECRUITING

CHU de Dijon

Dijon, France

ACTIVE NOT RECRUITING

CHU de Grenoble

Grenoble, France

RECRUITING

CH de La Rochelle

La Rochelle, 17019, France

RECRUITING

CH Versailles

Le Chesnay, France

RECRUITING

CHU de Lyon

Lyon, France

RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

Hôpital Paris Saint Joseph

Paris, France

RECRUITING

CH de Roanne

Roanne, France

RECRUITING

Hôpital Foch

Suresnes, France

RECRUITING

CH de Toulon

Toulon, France

RECRUITING

CHU Tours

Tours, France

ACTIVE NOT RECRUITING

Related Publications (1)

  • Legriel S, Bernard C, Sboui G, Sigaud F, Lascarrou JB, Mayenco-Cardenal N, Chelly J, Bruel C, Mongardon N, Marzouk M, Quenot JP, Hugues R, Schnell D, Beuret P, Bailly P, Lesieur O, Argaud L, Chambon R, Jacq G. Assessment of health-related quality of life, cognitive, physical and psychological impairments in critically ill adults after status epilepticus (POSEIDON 2): protocol for a multicentre longitudinal study. BMJ Open. 2026 Mar 3;16(3):e112563. doi: 10.1136/bmjopen-2025-112563.

    PMID: 41775483DERIVED

MeSH Terms

Conditions

Patient SatisfactionStatus Epilepticus

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorSeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gwenaelle Jacq, RN,MSc,PhDc

    CH Versailles

    STUDY DIRECTOR

  • Stephane Legriel, MD,PhD

    CH Versailles

    STUDY DIRECTOR

Central Study Contacts

Gwenaelle Jacq, RN,MSc,PhDc

CONTACT

33139638356gjacq@ght78sud.fr

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

October 15, 2023

First Posted

October 25, 2023

Study Start

May 25, 2024

Primary Completion (Estimated)

March 25, 2027

Study Completion (Estimated)

March 25, 2027

Last Updated

July 7, 2026

Record last verified: 2026-07

Locations

FR(19)