NCT07001410

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Dec 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 23, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
1.5 years until next milestone

Study Start

First participant enrolled

December 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

May 23, 2025

Last Update Submit

February 5, 2026

Conditions

Keywords

AgedFrail Older AdultsIntensive Care UnitsCritical IllnessColombia

Outcome Measures

Primary Outcomes (1)

  • ICU mortality

    Mortality during ICU stay.

    30 days

Secondary Outcomes (3)

  • ICU length of stay

    30 days

  • Invasive mechanical ventilation

    30 days

  • Duration of IMV

    30 days

Study Arms (3)

Younger adults

Critically ill patients, younger adults (\<65 years)

Other: Age group

Elders

Critically ill old patients (aged 65 to 79 years)

Other: Age group

Octogenarians

Very old critically ill patients (80 years old or more)

Other: Age group

Interventions

Observation of the outcomes by age groups.

EldersOctogenariansYounger adults

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults discharged from the intensive care unit during the study period, especially older adults and octogenarians.

You may qualify if:

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

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Departamental de Villavicencio

Villavicencio, Meta Department, 50001, Colombia

Location

Related Publications (12)

  • Heppner HJ, Haitham H. Intensive care of geriatric patients-a thin line between under- and overtreatment. Wien Med Wochenschr. 2022 Apr;172(5-6):102-108. doi: 10.1007/s10354-021-00902-1. Epub 2022 Jan 10.

  • Ball IM, Bagshaw SM, Burns KE, Cook DJ, Day AG, Dodek PM, Kutsogiannis DJ, Mehta S, Muscedere JG, Turgeon AF, Stelfox HT, Wells GA, Stiell IG. Outcomes of elderly critically ill medical and surgical patients: a multicentre cohort study. Can J Anaesth. 2017 Mar;64(3):260-269. doi: 10.1007/s12630-016-0798-4. Epub 2016 Dec 27.

  • Beil M, Flaatten H, Guidet B, Sviri S, Jung C, de Lange D, Leaver S, Fjolner J, Szczeklik W, van Heerden PV. The management of multi-morbidity in elderly patients: Ready yet for precision medicine in intensive care? Crit Care. 2021 Sep 10;25(1):330. doi: 10.1186/s13054-021-03750-y.

  • Beil M, Sviri S, Flaatten H, De Lange DW, Jung C, Szczeklik W, Leaver S, Rhodes A, Guidet B, van Heerden PV. On predictions in critical care: The individual prognostication fallacy in elderly patients. J Crit Care. 2021 Feb;61:34-38. doi: 10.1016/j.jcrc.2020.10.006. Epub 2020 Oct 13.

  • Shum HP, Chan KC, Wong HY, Yan WW. Outcome of elderly patients who receive intensive care at a regional hospital in Hong Kong. Hong Kong Med J. 2015 Dec;21(6):490-8. doi: 10.12809/hkmj144445. Epub 2015 Sep 29.

  • Rai S, Brace C, Ross P, Darvall J, Haines K, Mitchell I, van Haren F, Pilcher D. Characteristics and Outcomes of Very Elderly Patients Admitted to Intensive Care: A Retrospective Multicenter Cohort Analysis. Crit Care Med. 2023 Oct 1;51(10):1328-1338. doi: 10.1097/CCM.0000000000005943. Epub 2023 May 23.

  • Vincent JL, Creteur J. Appropriate care for the elderly in the ICU. J Intern Med. 2022 Apr;291(4):458-468. doi: 10.1111/joim.13371. Epub 2021 Oct 5.

  • Andersen FH, Ariansen Haaland O, Klepstad P, Flaatten H. Frailty and survival in elderly intensive care patients in Norway. Acta Anaesthesiol Scand. 2021 Sep;65(8):1065-1072. doi: 10.1111/aas.13836. Epub 2021 May 7.

  • Ramos JGR, Ranzani OT, Perondi B, Dias RD, Jones D, Carvalho CRR, Velasco IT, Forte DN. A decision-aid tool for ICU admission triage is associated with a reduction in potentially inappropriate intensive care unit admissions. J Crit Care. 2019 Jun;51:77-83. doi: 10.1016/j.jcrc.2019.02.002. Epub 2019 Feb 4.

  • Kim J, Choi SM, Park YS, Lee CH, Lee SM, Yim JJ, Yoo CG, Kim YW, Han SK, Lee J. Factors influencing the initiation of intensive care in elderly patients and their families: A retrospective cohort study. Palliat Med. 2016 Sep;30(8):789-99. doi: 10.1177/0269216316634241. Epub 2016 Mar 2.

  • Haas LEM, van Beusekom I, van Dijk D, Hamaker ME, Bakhshi-Raiez F, de Lange DW, de Keizer NF. Healthcare-related costs in very elderly intensive care patients. Intensive Care Med. 2018 Nov;44(11):1896-1903. doi: 10.1007/s00134-018-5381-8. Epub 2018 Sep 25.

  • Ferretti-Rebustini REL, Bispo NDS, Alves WDS, Dias TN, Santoro CM, Padilha KG. Level of acuity, severity and intensity of care of adults and older adults admitted to the Intensive Care Unit. Rev Esc Enferm USP. 2019 Jan 21;53:e03416. doi: 10.1590/S1980-220X2017051403416. English, Portuguese.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Norton Perez, MD

    Hospital Departamental de Villavicencio

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Norton Perez, MD

CONTACT

Emma I Rodriguez, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 3, 2025

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations