NCT07621276

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2026

Completed
Last Updated

June 2, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

May 27, 2026

Last Update Submit

May 27, 2026

Conditions

Keywords

Intensive Care UnitSAPS 3mFI-11Resource AllocationCritical

Outcome Measures

Primary Outcomes (1)

  • Total Real Hospital Cost

    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).

Study Arms (1)

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.

Interventions

The total monetary expenditure (expressed in Mexican Pesos) generated during the hospital stay, as recorded in the institutional financial database.

ICU Patient Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital H+ Querétaro, Santiago de Querétaro, Querétaro

Querétaro City, Querétaro, 7600, Mexico

Location

MeSH Terms

Conditions

FrailtyCritical Illness

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
17 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Efrain Aguila Velazquez Martinez

Study Record Dates

First Submitted

May 27, 2026

First Posted

June 2, 2026

Study Start

January 1, 2024

Primary Completion

May 31, 2025

Study Completion

June 1, 2025

Last Updated

June 2, 2026

Record last verified: 2026-05

Locations