Critical IllnessFORECASTNCT04605029
Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients
An observational study of Critical Illness, run by Dr. John Muscedere at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals who are admitted to an intensive care unit requiring therapeutic life support.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients - A Pilot Study
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.
Read the detailed description
Single Center Observational pilot study to inform on the conduct of a multi-center observational study.
- Conditions
- Critical Illness
- Keywords
- Frailty
- Medical subject headings
- Critical Illness, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically Ill patients | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with a measure of frailty prior to hospital discharge.
Measure of the Frailty Index and Clinical Frailty Scale prior to discharge
Measured: 6 months
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
Measured: 6 months
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
Measured: 28 days and at 6 months
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
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Aug 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. John Muscedere
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Frailty Network
- Responsible party
- Sponsor-investigator, Dr. John Muscedere, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605029
- Sponsor's protocol ID
- FORECAST
- Acronym
- FORECAST
- Status last verified
- Oct 2020
- First submitted
- 30 Oct 2018
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty, Outcomes, Recovery and Care Steps of Critically Ill Patients - A Pilot Study
- ClinicalTrials.gov ID
- NCT04605029
- Acronym / sponsor ID
- FORECAST / FORECAST
- Conditions
- Critical Illness
- Keywords
- Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dr. John MuscedereUniversity, hospital or other
- Collaborators
- Canadian Frailty Network
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically Ill patients | – | –No Intervention |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who are admitted to an intensive care unit requiring therapeutic life support.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Dr. John Muscedere at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with a measure of frailty prior to hospital discharge. (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.