FrailtyFG-UCINCT06793462
ASSESSMENT of FRAILTY AS a PROGNOSTIC FACTOR for MORTALITY, DISABILITY, and QUALITY of LIFE AFTER ICU ADMISSION
An observational study of Frailty and Frailty At Older Adults, run by Hospital Universitari Vall d'Hebron Research Institute.
Trial summary
Between 30% and 40% of elderly patients (over 70 years old) who require hospitalization and treatment in Intensive Care Units (ICU) exhibit a state of frailty. This condition is associated with adverse prognostic factors such as increased in-hospital mortality, functional decline, and a deterioration in their… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty, Frailty At Older Adults
- How many people
- 246 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: The study population will consist of all elderly patients (over 70 years old) requiring admission to ICU-Semi-critical units, with consecutive sampling for the treatment of life-threatening conditions based on the following selection criteria:
Who may be able to join
- Elderly patients over 70 years of age requiring admission to ICU-semicritical units.
- Patients receiving at least one life-support intervention for more than 24 hours, including:
- Mechanical ventilation (invasive or non-invasive),
- Vasopressor or inotropic treatment,
- Requirement for acute renal replacement therapies for more than 24 hours,
- Extracorporeal support such as:
- Veno-Venous Extracorporeal Membrane Oxygenation (ECMO-VV), Veno-Arterial Extracorporeal Membrane Oxygenation (ECMO-VA).
Who cannot join
- Patients with an ICU stay of less than 72 hours.
- Patients with treatment limitations upon ICU admission, although an isolated "Do Not Resuscitate" (DNR) order is acceptable; life expectancy of less than 6 months.
- Absence of family members or caregivers available to provide medical history. Language barriers (non-Spanish speakers without access to medical translators).
- Structural neurological diseases requiring ICU admission, including stroke or spinal cord pathology.
- Patients for whom 12-month follow-up is anticipated to be unfeasible.
- Patients without consent authorization.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Between 30% and 40% of elderly patients (over 70 years old) who require hospitalization and treatment in Intensive Care Units (ICU) exhibit a state of frailty. This condition is associated with adverse prognostic factors such as increased in-hospital mortality, functional decline, and a deterioration in their long-term quality of life. Some frail elderly patients may require invasive mechanical ventilation (ventilator) as life support during the acute phase, which has also been linked to adverse prognostic outcomes. Additionally, frailty is common in patients with severe infections, with a high mortality rate, subsequent functional decline, and reduced quality of life following ICU admission.
Read the detailed description
This project focuses on evaluating the role of geriatric frailty (FG) as a crucial predictive factor in various clinical aspects of elderly patients requiring admission to intensive care units (ICUs). Below is a breakdown of the project's main objectives for clarity:
Frailty as a predictor of mortality:
Assess whether frailty is an independent marker that predicts mortality over different timeframes (short, medium, and long term) in elderly patients admitted to the ICU.
Frailty and functional disability:
Determine whether frailty is associated with the evolution of functional disability in the short, medium, and long term following ICU admission.
Frailty and quality of life:
Analyze whether frailty can predict changes in the quality of life of elderly patients after their stay in the ICU, considering the same timeframes (short, medium, and long term).
Impact on patients requiring invasive mechanical ventilation (IMV):
Evaluate the impact of frailty on mortality, functional evolution, and quality of life in elderly patients requiring IMV.
Study the role of frailty as a prognostic factor for complications related to weaning from mechanical ventilation (tracheostomy, prolonged ICU or hospital stay, readmissions, and disability).
Frailty and sepsis/septic shock:
Investigate whether frailty is an independent prognostic marker for mortality in elderly patients with sepsis or septic shock admitted to the ICU.
This comprehensive approach aims not only to identify frailty as a key risk factor but also to guide management strategies and clinical decision-making for this particularly vulnerable population. If you need further elaboration or scientific drafting, feel free to ask!
- Conditions
- Frailty, Frailty At Older Adults
- Keywords
- FRAILTY AND ICU, PROGNOSTIC, ELDERLY, FUNCTIONAL, QUALITY OF LIFE
- Medical subject headings
- 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 |
|---|---|---|
| FRAILS AND NO FRAILS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MORTALITY
Determine whether frailty is a predictor of short-, medium-, and long-term mortality in elderly patients requiring ICU admission.
Measured: ONE YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- 246 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793462
- Sponsor's protocol ID
- PR(AG)348/2024
- Acronym
- FG-UCI
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ASSESSMENT of FRAILTY AS a PROGNOSTIC FACTOR for MORTALITY, DISABILITY, and QUALITY of LIFE AFTER ICU ADMISSION
- ClinicalTrials.gov ID
- NCT06793462
- Acronym / sponsor ID
- FG-UCI / PR(AG)348/2024
- Conditions
- Frailty, Frailty At Older Adults
- Keywords
- FRAILTY AND ICU, PROGNOSTIC, ELDERLY, FUNCTIONAL, QUALITY OF LIFE
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 27 Jan 2025 (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.
Between 30% and 40% of elderly patients (over 70 years old) who require hospitalization and treatment in Intensive Care Units (ICU) exhibit a state of frailty. This condition is associated with adverse prognostic factors such as increased in-hospital mortality, functional decline, and a deterioration in their long-term quality of life. Some frail elderly patients may require invasive mechanical ventilation (ventilator) as life support during the acute phase, which has also been linked to adverse prognostic outcomes. Additionally, frailty is common in patients with severe infections, with a high mortality rate, subsequent functional decline, and reduced quality of life following ICU admission.
Detailed description
This project focuses on evaluating the role of geriatric frailty (FG) as a crucial predictive factor in various clinical aspects of elderly patients requiring admission to intensive care units (ICUs). Below is a breakdown of the project's main objectives for clarity:
Frailty as a predictor of mortality:
Assess whether frailty is an independent marker that predicts mortality over different timeframes (short, medium, and long term) in elderly patients admitted to the ICU.
Frailty and functional disability:
Determine whether frailty is associated with the evolution of functional disability in the short, medium, and long term following ICU admission.
Frailty and quality of life:
Analyze whether frailty can predict changes in the quality of life of elderly patients after their stay in the ICU, considering the same timeframes (short, medium, and long term).
Impact on patients requiring invasive mechanical ventilation (IMV):
Evaluate the impact of frailty on mortality, functional evolution, and quality of life in elderly patients requiring IMV.
Study the role of frailty as a prognostic factor for complications related to weaning from mechanical ventilation (tracheostomy, prolonged ICU or hospital stay, readmissions, and disability).
Frailty and sepsis/septic shock:
Investigate whether frailty is an independent prognostic marker for mortality in elderly patients with sepsis or septic shock admitted to the ICU.
This comprehensive approach aims not only to identify frailty as a key risk factor but also to guide management strategies and clinical decision-making for this particularly vulnerable population. If you need further elaboration or scientific drafting, feel free to ask!
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FRAILS AND NO FRAILS | – | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- The study population will consist of all elderly patients (over 70 years old) requiring admission to ICU-Semi-critical units, with consecutive sampling for the treatment of life-threatening conditions based on the following selection criteria:
Key inclusion criteria (7 listed)
- Elderly patients over 70 years of age requiring admission to ICU-semicritical units.
- Patients receiving at least one life-support intervention for more than 24 hours, including:
- Mechanical ventilation (invasive or non-invasive),
- Vasopressor or inotropic treatment,
- Requirement for acute renal replacement therapies for more than 24 hours,
Key exclusion criteria (6 listed)
- Patients with an ICU stay of less than 72 hours.
- Patients with treatment limitations upon ICU admission, although an isolated "Do Not Resuscitate" (DNR) order is acceptable; life expectancy of less than 6 months.
- Absence of family members or caregivers available to provide medical history. Language barriers (non-Spanish speakers without access to medical translators).
- Structural neurological diseases requiring ICU admission, including stroke or spinal cord pathology.
- Patients for whom 12-month follow-up is anticipated to be unfeasible.
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
MORTALITY
Time frame: ONE YEAR
Determine whether frailty is a predictor of short-, medium-, and long-term mortality in elderly patients requiring ICU admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Frailty At Older Adults, run by Hospital Universitari Vall d'Hebron Research Institute.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DAVID S PEREZ, MD (+34 93 274 61 81, davidsalomon.perez@vallhebron.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MORTALITY (time frame: ONE YEAR). 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 Jan 2025.