Recovery After Intensive Care Study

Intensive Care Unit Syndrome Clinical Trial

— RAI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979741
• Other study ID #: CER Liguria: 350/2019
• Secondary ID: Protocol approva
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Follow up
• Intensive Care Unit Syndrome
• Outcome

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