Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT04608994
Status:
UNKNOWN
Last Update Posted:
2020-10-30
First Post:
2020-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Follow up in Survivors of Critical Illness
Sponsor:
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Organization:
Study Overview
Official Title:
Long-term Follow-up in Survivors of Critical Illness: An Longitudinal Assessment of Critically Ill Patients Discharged Alive From the Intensive Care Unit
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Survivors of critical illness may suffer from persistent physical, cognitive and mental impairments, such as muscle weakness, dysfunction in the memory and executive domains, post-traumatic stress disorders, depression, and anxiety. This syndrome is referred to as Post Intensive Care Syndrome (PICS).
This study aims to assess the frequency of impairments, their evolution over time, and to understand the pathogenetic mechanisms and the association between long-term sequelae and acute care events.
This study aims to assess the frequency of impairments, their evolution over time, and to understand the pathogenetic mechanisms and the association between long-term sequelae and acute care events.
Detailed Description:
PICS describes 'new or worsening impairments in physical, cognitive or mental health status arising after critical illness and persisting beyond acute care hospitalization'. Different critical care professional and scientific societies have identified long-term functional outcomes after critical illness as an important target for research and clinical improvements, and there is general agreement that research on PICS should be a priority for the critical care community.
Post-ICU subjects may experience physical problems, such as muscles weakness and wasting, caused by prolonged bed rest and immobility during the ICU stay and by critical illness polyneuropathy and myopathy developing during the acute illness; organ dysfunction; chronic pain; mental health problems including depression, anxiety or post-traumatic stress disorder (PTSD); and neurocognitive impairments which are predominantly represented by memory dysfunction and executive function impairment. The impact of these problems on the subject's health status is huge, which reduced quality of life, and impaired functional status, and daily functioning.
Many survivors incur substantial healthcare costs, lose employment, and find their social networks wholly changed. The costs to subjects and families are high: ICU survivorship is associated with decreased return to work, and the loss of earnings plagues both patients and caregivers.
Prior studies in which researchers have examined outcomes among ICU survivors have been mainly restricted their assessments to specific patient populations and have used only limited outcome measures or the follow-up period was relatively short-term. Moreover, few studies have explored the association between acute care events and long-term sequelae as well as the underlying pathophysiological mechanisms.
The researchers appertaining to the present study implemented a follow-up clinic to describe the frequency of physical, cognitive, and mental impairments and their evolution over time in subjects surviving critical illness. The researchers also aim at understanding the pathogenetic mechanisms underlying these impairments and their association with acute care events.
Post-ICU subjects may experience physical problems, such as muscles weakness and wasting, caused by prolonged bed rest and immobility during the ICU stay and by critical illness polyneuropathy and myopathy developing during the acute illness; organ dysfunction; chronic pain; mental health problems including depression, anxiety or post-traumatic stress disorder (PTSD); and neurocognitive impairments which are predominantly represented by memory dysfunction and executive function impairment. The impact of these problems on the subject's health status is huge, which reduced quality of life, and impaired functional status, and daily functioning.
Many survivors incur substantial healthcare costs, lose employment, and find their social networks wholly changed. The costs to subjects and families are high: ICU survivorship is associated with decreased return to work, and the loss of earnings plagues both patients and caregivers.
Prior studies in which researchers have examined outcomes among ICU survivors have been mainly restricted their assessments to specific patient populations and have used only limited outcome measures or the follow-up period was relatively short-term. Moreover, few studies have explored the association between acute care events and long-term sequelae as well as the underlying pathophysiological mechanisms.
The researchers appertaining to the present study implemented a follow-up clinic to describe the frequency of physical, cognitive, and mental impairments and their evolution over time in subjects surviving critical illness. The researchers also aim at understanding the pathogenetic mechanisms underlying these impairments and their association with acute care events.
Study Oversight
Has Oversight DMC:
False
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?: