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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04979741
Other study ID # CER Liguria: 350/2019
Secondary ID Protocol approva
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 1, 2023

Study information

Verified date July 2021
Source University of Genova
Contact Iole Brunetti, MD
Phone 010/5551
Email brunettimed@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 196
Est. completion date January 1, 2023
Est. primary completion date January 1, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No interventions
Observational study, no intervention is required

Locations

Country Name City State
Italy Policlinico San Martino Genova

Sponsors (1)

Lead Sponsor Collaborator
University of Genova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary To assess the incidence of post-discharge mortality in patients admitted in ICU. using a neuropsychological evaluation 12 months
Secondary Cognitive outcome assessed through the MoCA scale, Montreal Cognitive Assessment This is a scale including different tests regarding language, attention, naming giving a score from 0 (maximal cognitive dysfunction) and 30 ( no deficit) 12 months
Secondary Cognitive outcome assessed through HADS scale (Hospital Anxiety and Depression Scale) Questionnaire with score from 0 (no issues) to 21 (maximal abnormalities) exploring depression and anxiety 12 months
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