Patient-reported Outcome After Status Epilepticus

Intensive Care Unit Clinical Trial

— POSEIDON  

Official title:

Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05491590
• Other study ID #: P21/11 - POSEIDON
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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