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NCT Number: NCT04605029

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

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.

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Key information

Conditions

Critical Illness Disease Attributes Frailty Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Lack of consent for study inclusion or lack of consent to be contacted for long term follow-up.
  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months

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

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

    Time frame: 6 months

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

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

    Time frame: 28 days and at 6 months

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

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

    Time frame: 28 days

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

Sponsors and collaborators

Lead sponsor

Dr. John Muscedere

Other

Collaborators

  • Canadian Frailty Network

Registry information

Official study title

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

Acronym: FORECAST

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 27, 2020
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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