Clinical Trials Directory

Trials / Unknown

UnknownNCT04979741

Recovery After Intensive Care Study

Recovery After Intensive Care Study: a Single- Center Observational Study

Status
Unknown
Phase
Study type
Observational
Enrollment
196 (estimated)
Sponsor
University of Genova · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

Summary

Post-ICU long term sequelae- defined as "post intensive care syndrome" (PICS) manifest with a wide spectrum of psychological and cognitive impairments, affecting over two-thirds of ICU survivors and leading to increased rehospitalization, health care costs, impaired quality of life (QoL), inability to return to work and burden for families. 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.

Detailed description

This is a single center, prospective observational study, which will be conducted at Policlinico San Martino Hospital, Genova, Italy. Patients admitted to the ICU from more than 72 hours will be consecutively included during a 2 years period. 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

Interventions

TypeNameDescription
OTHERNo interventionsObservational study, no intervention is required

Timeline

Start date
2021-01-01
Primary completion
2021-01-01
Completion
2023-01-01
First posted
2021-07-28
Last updated
2021-07-28

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04979741. Inclusion in this directory is not an endorsement.