Frailty and Severity as Determinants of Hospital Cost in the ICU (FRESH-ICU)

May 27, 2026 updated by: Jose J Zaragoza, MD MSc, Hospital H+ Queretaro

Frailty and Severity as Determinants of Hospital Cost in the Intensive Care Unit: A Retrospective Cohort Study With Partial Economic Evaluation.

This study evaluated the association between baseline frailty (mFI-11) and acute illness severity (SAPS 3) with real hospital costs in adult patients admitted to the Intensive Care Unit (ICU). The objective was to determine if frailty and severity are independent predictors of resource consumption.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A retrospective cohort study was conducted at Hospital H+ Querétaro involving 142 adult patients admitted to the ICU between January 2024 and May 2025. Baseline frailty was calculated using the 11-item Modified Frailty Index (mFI-11), and acute severity was assessed with the SAPS 3 score. Total hospital costs were obtained from institutional financial records. Multivariate models were used to adjust for comorbidities (Charlson Index) and other clinical variables to identify independent determinants of hospital expenditure.

Study Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 7600
        • Hospital H+ Querétaro, Santiago de Querétaro, Querétaro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pacientes adultos (≥18 años) admitidos a la Unidad de Cuidados Intensivos del Hospital H+ Querétaro entre el 1 de enero de 2024 y el 31 de mayo de 2025. Se incluirán únicamente aquellos con expedientes clínicos completos que permitan el cálculo del índice de fragilidad modificado de 11 ítems (mFI-11), el puntaje de severidad SAPS 3 y el índice de comorbilidad de Charlson, así como disponibilidad de registros institucionales de costos hospitalarios reales. Se excluirán pacientes con información incompleta en variables principales, transferidos de otras instituciones sin datos basales suficientes, con inconsistencias significativas en los registros de costos, o reingresos en los que no sea posible atribuir de manera independiente los costos al episodio índice.

Description

Inclusion Criteria:

  • Patients aged 18 years or older.
  • Admission to the ICU between January 1, 2024, and May 31, 2025.
  • Complete medical records allowing for the calculation of mFI-11, SAPS 3, and Charlson Index.
  • Availability of institutional records regarding actual hospital costs.Exclusion Criteria:
  • Incomplete records for primary exposure or outcome variables.
  • Patients transferred from other institutions without sufficient baseline data.
  • Severe inconsistencies in cost records.
  • Subsequent readmissions where costs cannot be independently attributed to the index episode.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ICU Patient Cohort
All adult patients (≥18 years) admitted to the ICU during the study period with complete medical and financial records.
Other: Total Real Hospital Cost.
The total monetary expenditure (expressed in Mexican Pesos) generated during the hospital stay, as recorded in the institutional financial database.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Real Hospital Cost
Time Frame: From ICU admission to hospital discharge (approximately 17 months of data collection period).
The total monetary expenditure (in local currency) recorded in the institutional administrative database for the hospital episode, from admission to discharge or death.
From ICU admission to hospital discharge (approximately 17 months of data collection period).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital H+ Queretaro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

May 31, 2025

Study Completion (Actual)

June 1, 2025

Study Registration Dates

First Submitted

May 27, 2026

First Submitted That Met QC Criteria

May 27, 2026

First Posted (Actual)

June 2, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H+QRO-2026-FRAILTY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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