ASSESSMENT of FRAILTY AS a PROGNOSTIC FACTOR for MORTALITY, DISABILITY, and QUALITY of LIFE AFTER ICU ADMISSION

NCT ID: NCT06793462

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 246 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2027-01-01

Brief 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 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!

Conditions

Frailty; Frailty At Older Adults

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

FRAILS AND NO FRAILS

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

DAVID S PEREZ, MD

Role: CONTACT

davidsalomon.perez@vallhebron.cat

+34 93 274 61 81

Other Identifiers

PR(AG)348/2024

Identifier Type: -

Identifier Source: org_study_id