Clinical trial NCT04608994: Long-term Follow up in Survivors of Critical Illness
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Intensive Care Unit Syndrome
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
Collaborators: name: Università degli Studi di Brescia
First posted: 2020-10-30
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll all patients admitted to the ICUs with SARS-CoV-2 pneumonia and ARDS.

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.

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.

Eligibility criteria: Inclusion Criteria:

- All COVID-19 patients admitted to the ICUs of the Spedali Civili University Hospital in Brescia, Italy.

Exclusion Criteria:

- None

Primary outcomes:
measure: Medical Research Council (MRC) sum score
timeFrame: 3 months
measure: Medical Research Council (MRC) sum score
timeFrame: 6 months
measure: Medical Research Council (MRC) sum score
timeFrame: 12 months
measure: Dominand Handgrip Test
timeFrame: 3 months
measure: Dominand Handgrip Test
timeFrame: 6 months
measure: Dominand Handgrip Test
timeFrame: 12 months
measure: Six Minutes Walking Test
timeFrame: 3 months
measure: Six Minutes Walking Test
timeFrame: 6 months
measure: SIX Minutes Walking Test
timeFrame: 12 months
measure: Fatigue Severity Scale (FSS)
timeFrame: 3 months
measure: Fatigue Severity Scale (FSS)
timeFrame: 6 months
measure: Fatigue Severity Scale (FSS)
timeFrame: 12 months
measure: Elettromyography
timeFrame: 3 months
measure: Elettromyography
timeFrame: 6 months
measure: Elettromyography
timeFrame: 12 months
measure: Montreal Cognitive Assessment Test (MoCA)
timeFrame: 3 months
measure: Montreal Cognitive Assessment Test (MoCA)
timeFrame: 6 months
measure: Montreal Cognitive Assessment Test (MoCA)
timeFrame: 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 months
measure: The The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: 3 months
measure: The The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: 6 months
measure: The The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: 12 months
measure: Insomnia Severity Index (ISI)
timeFrame: 3 months
measure: Insomnia Severity Index (ISI)
timeFrame: 6 months
measure: Insomnia Severity Index (ISI)
timeFrame: 12 months
measure: The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
timeFrame: 3 months
measure: The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
timeFrame: 6 months
measure: The Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
timeFrame: 12 months
measure: Barthel Index (BI)
timeFrame: 3 months
measure: Barthel Index (BI)
timeFrame: 6 months
measure: Barthel Index (BI)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: ASST- Spedali Civili di Brescia
Study officials:
References:
citation: Latronico N, Peli E, Calza S, Rodella F, Novelli MP, Cella A, Marshall J, Needham DM, Rasulo FA, Piva S; LOTO Investigators. Physical, cognitive and mental health outcomes in 1-year survivors of COVID-19-associated ARDS. Thorax. 2022 Mar;77(3):300-303. doi: 10.1136/thoraxjnl-2021-218064. Epub 2021 Sep 29.