Recovery After Intensive Care Study

NCT04979741 | Unknown

• 2 other identifiers: CER Liguria: 350/2019Protocol approval
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Follow up; Outcome; Intensive Care Unit Syndrome

Keywords

intensive care unit; cognitive dysfunction; delirium

Outcome Measures

Primary Outcomes (1)

• To assess the incidence of post-discharge mortality in patients admitted in ICU.

  using a neuropsychological evaluation

  12 months

Secondary Outcomes (2)

• Cognitive outcome assessed through the MoCA scale, Montreal Cognitive Assessment

  12 months

• Cognitive outcome assessed through HADS scale (Hospital Anxiety and Depression Scale)

  12 months

Interventions

No interventions OTHER

Observational study, no intervention is required

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Genova: lead

Study Sites (1)

Policlinico San Martino

Genova, 16100, Italy

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Delirium

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Iole Brunetti, MD

CONTACT

010/5551; brunettimed@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 28, 2021
• Study Start: January 1, 2021
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2023
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: Request to the PI

Locations

IT (1)