Ignite Creation Date:
2024-05-06 @ 5:57 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05491590
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2022-08-01
Brief Title:
Patient-reported Outcome After Status Epilepticus
Sponsor:
Versailles Hospital
Organization:
Versailles Hospital
Study Overview
Official Title:
Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POSEIDON
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 patients 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
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 patients 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None