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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05491590
Other study ID # P21/11 - POSEIDON
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 9, 2022
Est. completion date March 1, 2024

Study information

Verified date February 2024
Source Versailles Hospital
Contact Gwenaelle JACQ, RN,MSc,PhDc
Phone 0139638356
Email gjacq@ght78sud.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 225
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
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 CHVersailles Le Chesnay Yvelines
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

Sponsors (1)

Lead Sponsor Collaborator
Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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 i)The Montreal Cognitive Assessment (MoCA)(Cognition)-Ranging score[0-30] a score of 26 and higher generally is considerednormal or Telephone MoCA-Ranging score[0-22],a score of 18 and higher generally is considered normal.
ii)The Glasgow Outcome Scale extended (Handicap)-Ranging score[1-8] a hight score indicate no handicap
iii) The Lawton IADL (scale contains eight items, with a summary score from 0 (low function) to 8 (high function). Each ability measured by the scale relies on either cognitive or physical function, though all require some degree of both.
and Barthel index (Dependency)-Ranging score[0-100], a high score indicate no dependency.
iv)The Hospital anxiety and depression (Anxiety,Depression)-Ranging score[0-21] a score > 8 indicate in each subscale a depresion or/and anxiety
v)The Impact of Event Scale -Revised(post traumatic syndrome disorder)-Ranging score[0-88],scores higher than 24 are of concern; the higher scores indicate the severity of PTSD
one day
Secondary 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. -QOLIE 31 measure of spécific QoL of epileptics patients, 30 items are organized into seven subscales:Ranging score[0-100], a high score indicate better health status. one day
Secondary 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) 36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status.
QOLIE 31 measure of spécific QoL of epileptics patients, 30 items are organized into seven subscales:Ranging score[0-100], a high score indicate better health status.
one day
Secondary Presence or absence Post-ICU factors associed to the PICs, as defined above in patients managed in the ICU for or with SE. cf outcomes 2 one day
Secondary Presence or absence of the elements associated with the PICs, as defined above, in the subgroups defining SE (SE with orwithout predominant motor signs,). i)The Montreal Cognitive Assessment (MoCA)(Cognition)-Ranging score[0-30] a score of 26 and higher generally is considerednormal or Telephone MoCA-Ranging score[0-22],a score of 18 and higher generally is considered normal.
ii)The Glasgow Outcome Scale extended (Handicap)-Ranging score[1-8] a hight score indicate no handicap
iii) The Lawton IADL (scale contains eight items, with a summary score from 0 (low function) to 8 (high function). Each ability measured by the scale relies on either cognitive or physical function, though all require some degree of both.
and Barthel index (Dependency)-Ranging score[0-100], a high score indicate no dependency.
iv)The Hospital anxiety and depression (Anxiety,Depression)-Ranging score[0-21] a score > 8 indicate in each subscale a depresion or/and anxiety
v)The Impact of Event Scale -Revised(post traumatic syndrome disorder)-Ranging score[0-88],scores higher than 24 are of concern; the higher scores indicate the severity of PTSD
one day
Secondary Presence or absence Post-ICU factors associated of return to work ability in patients managed in the ICU for or with SE. A return to work or school will be interpreted by the structured GOS interview. one day
Secondary score of perceived social support by the SSQ6 scale in its 2 dimensions, satisfaction and availability. The Social Support Questionnaire- Short Form-SSQ6 / 6 item measure of social support, with scores ranging from 0 (no social support) to 6 (very high social) and 1 (very dissatisfied) to 6 (very satisfied) for the area of satisfaction in each item or area. From these scores in the 6 domains, an average score was calculated for the number of supports available -Ranging score[0-54] and for satisfaction.Ranging score[0-36] one day
Secondary percentage of the quality of life impairement in the total population and in in the SE sub-groups patients identified with an previous epilepsy 36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status.
QOLIE 31 measure of spécific QoL of epileptics patients, 30 items are organized into seven subscales:Ranging score[0-100], a high score indicate better health status.
one day
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