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

NCT06793462 | Not Yet Recruiting

• 1 other identifier: PR(AG)348/2024
• Study Type: observational
• Target: 246
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Frailty; Frailty At Older Adults

Keywords

FRAILTY AND ICU; PROGNOSTIC; ELDERLY; FUNCTIONAL; QUALITY OF LIFE

Outcome Measures

Primary Outcomes (1)

• MORTALITY

  Determine whether frailty is a predictor of short-, medium-, and long-term mortality in elderly patients requiring ICU admission.

  ONE YEAR

Study Arms (1)

FRAILS AND NO FRAILS

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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:

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

DAVID S PEREZ, MD

CONTACT

+34 93 274 61 81; davidsalomon.perez@vallhebron.cat

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 27, 2025

Record last verified: 2025-01