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

Critical Illness Clinical Trial

— FORECAST  

Official title:

Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients - A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605029
• Other study ID #: FORECAST
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Frailty

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Dr. John Muscedere	Canadian Frailty Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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