Clinical trial NCT04605029: Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients
Official title: Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients - A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Frailty
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Canadian Frailty Network
First posted: 2020-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who are admitted to an intensive care unit requiring therapeutic life support.

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.

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

Eligibility 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

Primary outcomes:
measure: Number of patients with a measure of frailty prior to hospital discharge.
timeFrame: 6 months
measure: Correlation of frailty severity at hospital discharge with long term outcomes (mortality, Quality of Life and Need for Institutionalization)
timeFrame: 6 months
measure: Impact of admission critical illness on the development and severity of frailty as measured by a Frailty Index or Clinical Frailty Scale
timeFrame: 28 days and at 6 months
measure: Correlation of ICU processes of care (nutritional adequacy, mobilization and sedation) with frailty progression as measured by the Clinical Frailty Scale or Frailty Index
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
References: