FrailtyFRESH-ICUNCT07621276
Frailty and Severity as Determinants of Hospital Cost in the ICU
An observational study of Frailty and Critical Illness, run by Hospital H+ Queretaro at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frailty, Critical Illness, Hospital Costs
- What is being tested?
- Total Real Hospital Cost.
- How many people
- 142 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jan 2024to 1 Jun 2025
- How long will I take part?
- 17 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital H+ Querétaro, Santiago de Querétaro, Querétaro
Querétaro City, Querétaro, 7600
About this study
Official title: 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.
Read the 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.
- Conditions
- Frailty, Critical Illness, Hospital Costs
- Being tested
- Total Real Hospital Cost.
- Keywords
- Intensive Care Unit, SAPS 3, mFI-11, Resource Allocation, Critical
- Medical subject headings
- Frailty, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Real Hospital Cost.Other
The total monetary expenditure (expressed in Mexican Pesos) generated during the hospital stay, as recorded in the institutional financial database.
| Study group | Role | What they receive |
|---|---|---|
| ICU Patient Cohort | All adult patients (≥18 years) admitted to the ICU during the study period with complete medical and financial records. Receives: Other: Total Real Hospital Cost. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU admission to hospital discharge (approximately 17 months of data collection period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jan 2024
- Primary completion31 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
- Target duration
- 17 Months
Sponsor and investigators
- Lead sponsor
- Hospital H+ Queretaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD MSc, Hospital H+ Queretaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621276
- Sponsor's protocol ID
- H+QRO-2026-FRAILTY
- Acronym
- FRESH-ICU
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty and Severity as Determinants of Hospital Cost in the Intensive Care Unit: A Retrospective Cohort Study With Partial Economic Evaluation.
- ClinicalTrials.gov ID
- NCT07621276
- Acronym / sponsor ID
- FRESH-ICU / H+QRO-2026-FRAILTY
- Conditions
- Frailty, Critical Illness, Hospital Costs
- Keywords
- Intensive Care Unit, SAPS 3, mFI-11, Resource Allocation, Critical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Hospital H+ QueretaroUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 17 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU Patient Cohort | – | Other: Total Real Hospital Cost.All adult patients (≥18 years) admitted to the ICU during the study period with complete medical and financial records. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Real Hospital Cost.The total monetary expenditure (expressed in Mexican Pesos) generated during the hospital stay, as recorded in the institutional financial database. | Other | ICU Patient Cohort |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Critical Illness, run by Hospital H+ Queretaro at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Real Hospital Cost (time frame: From ICU admission to hospital discharge (approximately 17 months of data collection period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.