Clinical trial NCT07001410: Geriatrics in the Intensive Care Unit
Official title: Geriatrics in the Intensive Care Unit. An Observational Clinical Trial.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Geriatrics
Keywords: Aged
Frail Older Adults
Intensive Care Units
Critical Illness
Colombia
Lead sponsor: Hospital Departamental de Villavicencio
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults discharged from the intensive care unit during the study period, especially older adults and octogenarians.

Brief summary: Life expectancy is longer in populations of medium- and high-income countries. Older adults are an increasingly large population in intensive care units (ICUs). There are limited publications about the epidemiology, benefits, expenditure, and outcomes of elderly and very old critically ill patients.

We are designing a study to characterize older adults admitted to the intensive care unit and determine factors associated with adverse outcomes. The discharge registry of the ICU of a third-level hospital was reviewed. Records from January to December 2024 were reviewed. Three age groups were selected for comparison: A. \<65 years; B. 65-79 years; C. 80 years and above. The outcomes to compare will be: mortality, need for invasive mechanical ventilation, ICU length of stay, and duration of mechanical ventilation.

Detailed description: Background: Older adults represent a significant and increasing proportion of patients admitted to the intensive care unit, as the population's life expectancy is longer. The study aims to investigate factors associated with mortality in geriatric patients receiving critical care.

Methodology: We are designing a retrospective analytical cross-sectional clinical trial. The discharge records from January to December 2024 of one of the intensive care units (ICUs) from the Orinoco region in Colombia will be reviewed. The records will be divided into three groups for comparison: A. Lower than 65 years; B. between 65 and 79 years; C. 80 years and older. The records of patients admitted to the intermediate unit will be excluded. Outcomes to be evaluated will include mortality, ICU length of stay, invasive mechanical ventilation (IMV), and duration of IMV. The data will be exported to Excel. The frequency and proportion of categorical variables will be described. The central distribution and dispersion of quantitative variables will also be defined. Chi-square and Mann-Whitney U tests will be used for the statistical comparison of the variables. A value \<0.05 of p will be designated as statistical significance.

Results: The frequency of older adults admitted to the ICU will be revealed at the end of the study. The outcomes and factors associated with mortality by age groups will be discriminated.

Conclusions: The study is feasible, pertinent, affordable, and essential for the region, as it will optimize resource planning and improve healthcare for critically ill older adults.

Eligibility criteria: Inclusion Criteria:

* Registry of adults older than 18 years, discharged from the critical care unit.

Exclusion Criteria:

* None.

Primary outcomes:
measure: ICU mortality
timeFrame: 30 days
Secondary outcomes:
measure: ICU length of stay
timeFrame: 30 days
measure: Invasive mechanical ventilation
timeFrame: 30 days
measure: Duration of IMV
timeFrame: 30 days
Other outcomes:
Locations:
city: Villavicencio
country: Colombia
facility: Hospital Departamental de Villavicencio
state: Meta
Study officials:
affiliation: Hospital Departamental de Villavicencio
name: Norton Perez, MD
role: PRINCIPAL_INVESTIGATOR
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