ASSESSMENT of FRAILTY AS a PROGNOSTIC FACTOR for MORTALITY, DISABILITY, and QUALITY of LIFE AFTER ICU ADMISSION (FG-UCI)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty; Frailty At Older Adults

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 Type: Observational
• Enrollment (Estimated): 246

Contacts and Locations

• Study Contact: Name: DAVID S PEREZ, MD; Phone Number: +34 93 274 61 81; Email: davidsalomon.perez@vallhebron.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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:

Description

Inclusion criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
FRAILS AND NO FRAILS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MORTALITY	Determine whether frailty is a predictor of short-, medium-, and long-term mortality in elderly patients requiring ICU admission.	ONE YEAR

Collaborators and Investigators

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: QUALITY OF LIFE; ELDERLY; FRAILTY AND ICU; PROGNOSTIC; FUNCTIONAL
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: PR(AG)348/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No