Skip to content

Recovery After Intensive Care Study

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04979741
Acronym
RAI
Enrollment
196
Registered
2021-07-28
Start date
2021-01-01
Completion date
2023-01-01
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Follow up, Intensive Care Unit Syndrome, Outcome

Keywords

intensive care unit, cognitive dysfunction, delirium

Brief 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.

Interventions

OTHERNo interventions

Observational study, no intervention is required

Sponsors

University of Genova
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Age ≥ 18 years; * All patients acutely admitted in the ICU from \>72 hours, for both medical and surgical pathologies.

Exclusion criteria

* Pregnancy; * Refuse of consent to enrolment of patient or of the doctor required to give his approval.

Design outcomes

Primary

MeasureTime frameDescription
To assess the incidence of post-discharge mortality in patients admitted in ICU.12 monthsusing a neuropsychological evaluation

Secondary

MeasureTime frameDescription
Cognitive outcome assessed through HADS scale (Hospital Anxiety and Depression Scale)12 monthsQuestionnaire with score from 0 (no issues) to 21 (maximal abnormalities) exploring depression and anxiety
Cognitive outcome assessed through the MoCA scale, Montreal Cognitive Assessment12 monthsThis is a scale including different tests regarding language, attention, naming giving a score from 0 (maximal cognitive dysfunction) and 30 ( no deficit)

Countries

Italy

Contacts

Primary ContactIole Brunetti, MD
brunettimed@gmail.com010/5551

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026