Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients

NCT04605029 | Completed

• 1 other identifier: FORECAST
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Frailty

Outcome Measures

Primary Outcomes (4)

• Number of patients with a measure of frailty prior to hospital discharge.

  Measure of the Frailty Index and Clinical Frailty Scale prior to discharge

  6 months

• Correlation of frailty severity at hospital discharge with long term outcomes (mortality, Quality of Life and Need for Institutionalization)

  Clinical outcomes at 6 months will include mortality, Quality of Life (EQ5L) and need for Institutionalization

  6 months

• Impact of admission critical illness on the development and severity of frailty as measured by a Frailty Index or Clinical Frailty Scale

  Correlation with the progression or presence of frailty as measured with the Frailty Index or Clinical Frailty Scale

  28 days and at 6 months

• Correlation of ICU processes of care (nutritional adequacy, mobilization and sedation) with frailty progression as measured by the Clinical Frailty Scale or Frailty Index

  Correlation of processes of care in ICU (nutritional adequacy, mobilization and sedation) with frailty progression

  28 days

Study Arms (1)

Critically Ill patients

No Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age \> 55 years
• Admission to ICU for over 24 hours
• 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.

You may not qualify if:

• Expected to survive for less than 72 hours after ICU admission.
• 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).
• No family or caregivers available to collect collateral history.
• Not able to speak English with lack of available medical translators.
• Admission to ICU with acute structural neurological disease:
• Massive stroke requiring ICU care
• Spinal cord injury with neurological deficit

Sponsors & Collaborators

• Dr. John Muscedere: lead
• Canadian Frailty Network: collaborator

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cytokine levels and measures of immunocompetence

MeSH Terms

Conditions

Critical Illness; Frailty

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Critical Care Research Director

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: October 27, 2020
• Study Start: August 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: October 27, 2020

Record last verified: 2020-10

Locations

CA (1)