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

NCT ID: NCT04605029

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-12-31

Brief Summary

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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

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

Conditions

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Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Critically Ill patients

No Intervention

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Frailty Network

OTHER

Sponsor Role collaborator

Dr. John Muscedere

OTHER

Sponsor Role lead

Responsible Party

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Dr. John Muscedere

Critical Care Research Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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FORECAST

Identifier Type: -

Identifier Source: org_study_id