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

Completed

• Conditions: Critical Illness

• Registration Number: NCT04605029
• Lead Sponsor: Dr. John Muscedere

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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2018-10-30
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-21
• Last Update Submitted: 2020-10-21
• Study First Posted: 2020-10-27
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kingston Health Sciences Centre; 🇨🇦 Kingston, Ontario, Canada