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ClinicalTrials.gov ID

NCT06308835

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

100Estimated

Last Update Posted

Mar 18, 2024Actual

Start Date

May 2024Estimated

Primary Completion Date

Aug 2025Estimated

Completion Date

Aug 2025Estimated

Official Title

Prevalence and Risk Factors of Post Intensive Care Syndrome at 3 Months of an Intensive Care Unit Stay for a Neurological Disease

Brief Summary

Post-intensive care syndrome (PICS) is the set of disabling symptoms that can appear or worsen following a stay in intensive care. These symptoms are physical, cognitive, or psychiatric. The onset and persistence of these symptoms have a major impact on patients' quality of life, their autonomy, and their social and professional reintegration. patients with neurological diseases are frequently excluded from studies due to difficulties for the non-specialist resuscitator to perform the neurological examination and assess whether the symptoms of RPS are secondary to brain damage or complications inherent in resuscitation.The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it.

Detailed Description

"Post-intensive care syndrome (PICS) is defined as a new or worsening impairment in physical, cognitive or mental health status arising and persisting after a stay in intensive care unit (ICU) . The onset and persistence of these symptoms have a major impact on patients' quality of life, their autonomy, and their social and professional reintegration. PICS is very common, and more than half of ICU adult patients experience such impairments.

Recent French guidelines about PICS have been published and implemented to raise awareness among clinicians and patients about diagnosis and management of PICS .

A systematic ICU follow-up consultation by trained practitioners allows the diagnosis of PICS, and the implementation of appropriate curative measures to minimize sequelae and improve outcomes . This consultation is increasingly recommended by learned societies.

Incidence and risk factors of PICS is poorly known in patients with neurological diseases, because they are frequently excluded from PICS studies due to difficulties to assess whether the symptoms are disease-related or directly associated with the experience of a critical illness. A better knowledge of follow up of these patients is necessary to identify if some neurocognitive sequelae may be preventable or treatable.

The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it.

The investigators wish to conduct a bi-centric prospective study, in two neurological ICU in Paris (AP-HP Sorbonne université - Pitié Salpetrière hospital and Paris Cité -Saint Anne Hospital). The study will last one year.

It will included adults patients hospitalized >24h in neuro-ICU for a neurological disease affecting the central nervous system (status epilepticus, encephalitis, subarachnoid haemorrhage…) or the peripheral nervous system (myasthenia gravis crisis, Guillain-Barre syndrome…) ; and having received ICU lifesaving treatments (mechanical ventilation; sedation; plasmapheresis, renal replacement therapy, catecholamine).

Were excluded pregnant women, patients with pre-existing neurodegenerative disease or pre-existing severe psychiatric illness, and patients whose neurological or psychiatric history were not known prior to ICU. Patients with blindness, deafness, inability to speak French, active substance abuse, homelessness, or who lived > 100 kilometers from the enrolling center.

Patients will be recruited at the end of the ICU stay, patient's non-opposition will be collected. If the patient is unable to consent, the non-opposition of the person of trust will be collected.

As close as possible to the ICU discharge, a neurological examination, a MRC score, a MOCA scale, and a HADS scale will be performed.

The ICU-follow up visit will be planned 3 months +- 30 days from the ICU discharge and will include:

• An interview conducted by a trained neuro-intensivist with assessment of neurological symptoms and autonomy assessed by the Glasgow Outcome Scale extended (GOS-e), and the modified Rankin Scale (mRS), of psychiatric symptoms with self-reported questionnaires: Hospital Anxiety and Depression Scale (HADS) and the impact of event scale (IES-R).
• A physical assessement by a physiotherapist including a Medical research coucil score (MRC)
• A neuropsychological assessement by a neuropsychologist including a Montreal Cognitive Assessment (MOCA), batterie d'efficience frontale (BREF), Symbol Digit Modalities Test (SDMT), Trail Making Test (TMT), Empans verbaux, Boston naming Test (BNT)

• Post Intensive Care Syndrome

• questionnaires

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No data available

Eligibility Criteria

Inclusion Criteria:

• 1. Patient with > 24h stay in intensive care unit
• 2.Patients with a neurological disease affecting the central or peripheral nervous system, which is the reason for their hospitalization in intensive care.
• 3. Patients who have received organ replacement or invasive therapy in the ICU (invasive or non-invasive ventilation, extra-renal purification, plasmapheresis, ventricular bypass, catecholamines).
• 4. Non-opposition of the patient or of the trusted support person, or of a family member or close friend if the patient is unable to express non-opposition.

Exclusion Criteria:

• 1. Minors, protected adults and pregnant women
• 2. Advanced neurodegenerative disease pre-existing prior to ICU admission
• 3. Severe psychotic disorders pre-existing before admission to intensive care
• 4. Patients whose neurological and psychiatric history is unknown prior to resuscitation

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

c.legouy@ghu-paris.fr0145656200 ext. 33