Recovery After Intensive Care Study

• Conditions: Outcome; Intensive Care Unit Syndrome; Follow up

• Registration Number: NCT04979741
• Lead Sponsor: University of Genova

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-01-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-16
• Last Update Submitted: 2021-07-16
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28
• Study Completion: 2023-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 196

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the incidence of post-discharge mortality in patients admitted in ICU.	12 months	using a neuropsychological evaluation

Secondary Outcome Measures

Name	Time	Method
Cognitive outcome assessed through the MoCA scale, Montreal Cognitive Assessment	12 months	This is a scale including different tests regarding language, attention, naming giving a score from 0 (maximal cognitive dysfunction) and 30 ( no deficit)
Cognitive outcome assessed through HADS scale (Hospital Anxiety and Depression Scale)	12 months	Questionnaire with score from 0 (no issues) to 21 (maximal abnormalities) exploring depression and anxiety

Trial Locations

Locations (1)

Policlinico San Martino; 🇮🇹 Genova, Italy