Recovery After Intensive Care Study (RAI)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Unit Syndrome; Outcome; Follow up
• Intervention / Treatment: Other: No interventions

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 Type: Observational
• Enrollment (Anticipated): 196

Contacts and Locations

• Study Contact: Name: Iole Brunetti, MD; Phone Number: 010/5551; Email: brunettimed@gmail.com

Study Locations

• Italy
  • Genova, Italy, 16100
    • Recruiting
    • Policlinico San Martino
    • Contact: Iole Brunetti, MD; Phone Number: 010/55510; Email: brunettimed@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU from more than 72 hours will be consecutively included during a 2 years period

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the incidence of post-discharge mortality in patients admitted in ICU.	using a neuropsychological evaluation	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Genova

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2021
• Study Completion (Anticipated): January 1, 2023

Study Registration Dates

• First Submitted: July 7, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: intensive care unit; delirium; cognitive dysfunction
• Other Study ID Numbers: CER Liguria: 350/2019; Protocol approval (Other Identifier: Genova)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: IPD will be available for reasonable request to the PI
• IPD Sharing Access Criteria: Request to the PI
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No