Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
196 participants
OBSERVATIONAL
2021-01-01
2023-01-01
Brief Summary
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The prevalence of post-traumatic stress symptoms (PTSD), anxiety symptoms, and depression after ICU stay is high and has been demonstrated in up to 50% of post-ICU population.
Therefore, over the last years, an important effort has been made for the development of ICU aftercare and follow-up clinics with the aim to detect and to minimize post-ICU sequelae and improve outcomes. However, the utility of these follow-up programs and their effect on outcome has not been completely demonstrated.
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Detailed Description
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The primary objective is to assess the incidence of post-discharge mortality in patients admitted in ICU at 12 months.
Secondary objectives include the evaluation at 3, 6 and 12 months of outcome of patients admitted in ICU assessing QoL, anxiety, depression, PTSD, physical ability, cognitive function, sleep disorder and return to previous life; Self- and observer reported cognitive disability at 6 and 12 months after ICU discharge; prognostic factors for poor outcome, and emotional and burden of care impact on the patient's caregivers.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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No interventions
Observational study, no intervention is required
Eligibility Criteria
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Inclusion Criteria
* All patients acutely admitted in the ICU from \>72 hours, for both medical and surgical pathologies.
Exclusion Criteria
* Refuse of consent to enrolment of patient or of the doctor required to give his approval.
18 Years
ALL
No
Sponsors
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University of Genova
OTHER
Responsible Party
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Paolo Pelosi
Professor
Locations
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Policlinico San Martino
Genova, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Protocol approval
Identifier Type: OTHER
Identifier Source: secondary_id
CER Liguria: 350/2019
Identifier Type: -
Identifier Source: org_study_id
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