Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients (FORECAST) Study Multi-Center Study

NCT ID: NCT05509036

Last Updated: 2023-12-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-06-01

Brief Summary

A prospective observational study of critically ill patients over the age of 50, studying the occurrence of frailty as measured by a variety of frailty measures, processes of care and long term outcomes.

Detailed Description

Frailty is common in critically ill elderly patients, and is associated with adverse impacts on outcomes and is becoming increasingly common in Intensive Care Unit (ICU) populations. However it is not clear as to how to best measure frailty and when to do so. It is also not clear as to how processes of care impact on the outcomes observed. We hypothesize that frailty in survivors of critical illness will be measurable at hospital discharge, will correlate with processes of care while in ICU and will better discriminate long term outcomes when compared to severity of illness or the degree of frailty present on ICU admission.

Conditions

Frailty; Critical Illness

Keywords

Outcomes; Frailty

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Critically ill patients

Critically ill adults \> 50 admitted to the ICU and receiving a life support intervention

No interventions

Intervention Type: OTHER

No interventions

Interventions

No interventions

No interventions

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Must Meet both 1 and 2

• 1. Age > 50 years. We have selected >50 years in keeping with prior descriptions of critically ill patients [17].

2. Receipt of at least one of the following life support interventions for over 24 hours:

1. Mechanical ventilation: Both invasive and non-invasive either solely or in combination are acceptable. High flow oxygen (e.g. OPTIFLOW) as a form of Non-Invasive Ventilation (NIV) is acceptable but the patient's Fraction of Inspired Oxygen (FIO2) at the time of enrollment must be greater > 50%.

2. Vasoactive medications (vasopressors or inotropes).

3. Acute renal replacement therapy (RRT). Patient must have been admitted to ICU for the receipt of renal replacement therapy, either intermittent or continuous and after 24 hours of ICU admission, there is a continued need for further RRT.

Exclusion Criteria

1. ICU admission greater than 5 days at the time of enrollment.

2. Expected to survive for less than 72 hours after study enrollment.

3. No family or caregivers available to collect collateral history.

4. Family or caregivers not able to speak English or French.

5. Projected inability to complete 6 month follow-up either by telephone or in-person.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Frailty Network

OTHER

Sponsor Role: collaborator

Dr. John Muscedere

OTHER

Sponsor Role: lead

Responsible Party

Dr. John Muscedere

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John Muscedere, MD

Role: PRINCIPAL_INVESTIGATOR

Queens University

Locations

University of Alberta

Edmonton, Alberta, Canada

Dalhousie University - QEII

Halifax, Ontario, Canada

St Joe's Hamilton

Hamilton, Ontario, Canada

Kingston Health Sciences Center

Kingston, Ontario, Canada

London Health Sciences Centre

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Laval University

Laval, Quebec, Canada

Hôpital du Sacré-Cœur de Montréal

Montreal, Quebec, Canada

Maisonneuve Rosemont

Montreal, Quebec, Canada

McGill University

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

FORECAST, V4 - June 7, 2019

Identifier Type: -

Identifier Source: org_study_id