Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients (FORECAST)

• ClinicalTrials.gov Identifier: NCT04605029
• Recruitment Status: Completed
• First Posted: October 27, 2020
• Last Update Posted: October 27, 2020
• Sponsor: Dr. John Muscedere
• Collaborator: Canadian Frailty Network
• Information provided by (Responsible Party): Dr. John Muscedere, Queen's University

Study Description

Brief Summary:

This pilot study will study the impact of critical illness and ICU processes of care on the trajectory and development of frailty. It is 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.

This pilot study will be conducted in a tertiary medical surgical ICU at Kingston General Hospital- Kingston, Ontario. It will inform the feasibility, timelines and sample size for the multi-center study and will allow for the refinement of study procedures and data collection methods. This study will be published separately as a stand-alone pilot.

Condition or disease
Critical Illness

Detailed Description:

Single Center Observational pilot study to inform on the conduct of a multi-center observational study.

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients - A Pilot Study
• Actual Study Start Date: August 1, 2017
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Groups and Cohorts

Group/Cohort
Critically Ill patients; No Intervention

Outcome Measures

Primary Outcome Measures :

1. Number of patients with a measure of frailty prior to hospital discharge. [ Time Frame: 6 months ]
   Measure of the Frailty Index and Clinical Frailty Scale prior to discharge
2. Correlation of frailty severity at hospital discharge with long term outcomes (mortality, Quality of Life and Need for Institutionalization) [ Time Frame: 6 months ]
   Clinical outcomes at 6 months will include mortality, Quality of Life (EQ5L) and need for Institutionalization
3. Impact of admission critical illness on the development and severity of frailty as measured by a Frailty Index or Clinical Frailty Scale [ Time Frame: 28 days and at 6 months ]
   Correlation with the progression or presence of frailty as measured with the Frailty Index or Clinical Frailty Scale
4. Correlation of ICU processes of care (nutritional adequacy, mobilization and sedation) with frailty progression as measured by the Clinical Frailty Scale or Frailty Index [ Time Frame: 28 days ]
   Correlation of processes of care in ICU (nutritional adequacy, mobilization and sedation) with frailty progression

Biospecimen Retention:   Samples Without DNA

Cytokine levels and measures of immunocompetence

Eligibility Criteria

• Ages Eligible for Study: 55 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Individuals who are admitted to an intensive care unit requiring therapeutic life support.

Criteria

Inclusion Criteria:

1. Age > 55 years
2. Admission to ICU for over 24 hours
3. Receipt of at least one therapeutic life support intervention that can only be delivered in the ICU such as mechanical ventilation (both invasive and non-invasive), vasoactive medications (vasopressors or inotropes) or acute renal replacement therapy.

Exclusion Criteria:

1. Lack of consent for study inclusion or lack of consent to be contacted for long term follow-up.
2. Expected to survive for less than 72 hours after ICU admission.
3. Inability to obtain baseline blood work less than 48 hours after ICU admission (i.e. study enrollment must occur within 48 hours of ICU admission allowing for the blood work to be done in the time allowed).
4. No family or caregivers available to collect collateral history.
5. Not able to speak English with lack of available medical translators.

6. Admission to ICU with acute structural neurological disease:

   1. Massive stroke requiring ICU care
   2. Spinal cord injury with neurological deficit

Contacts and Locations

Locations

Canada, Ontario

Kingston Health Sciences Centre

Kingston, Ontario, Canada, K7L 2V7

Sponsors and Collaborators

Dr. John Muscedere

Canadian Frailty Network

More Information

• Responsible Party: Dr. John Muscedere, Critical Care Research Director, Queen's University
• ClinicalTrials.gov Identifier: NCT04605029
• Other Study ID Numbers: FORECAST
• First Posted: October 27, 2020
• Last Update Posted: October 27, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. John Muscedere, Queen's University:

Frailty

Additional relevant MeSH terms:

Critical Illness; Frailty; Disease Attributes; Pathologic Processes