Factor Associated With Mortality in the ICU (ICUMortal)

May 25, 2026 updated by: Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio

Factors Associated With Mortality in the Intensive Care Unit From the Orinoco Region. An Observational Trial

ICU mortality indicates the severity of disease, healthcare quality, and the efficacy of interventions. The severity scores are tools to predict the risk of mortality in the ICU, and the APACHE II score is frequently used for this purpose. However, studies validating the score in Colombia are limited. There is uncertainty about the precision and discrimination capacity of the APACHE II score in a population that varies from the original, with varying diseases, and in a different timeline. The investigators determined to evaluate: 1. Evaluate the rate of mortality in the ICU by type of disease and type of admission. 2. The factors associated with mortality. 3. Validate the performance of the APACHE II score as a predictor of mortality.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Introduction Mortality serves as an indicator of healthcare quality in the intensive care unit. The APACHE II score is a practical tool for predicting mortality, though its application varies. Studies validating the APACHE II score in Colombia are limited. This study aimed to evaluate the performance of the Acute Physiology and Chronic Health Evaluation (APACHE) II score as a predictor of mortality in the intensive care unit of a hospital in Villavicencio, Colombia.

Methodology Design: In this single-center, retrospective cohort, consecutive cases were observed from admission to discharge from the ICU. The demographic characteristics, diagnosis type, admission origin, and APACHE II score were systematically calculated on a database, and the cases were divided into two populations for comparison based on the outcome.

Setting: The study was performed in the ICU of Hospital Departamental de Villavicencio, a reference institution for the Orinoco region. It has 350 beds, four adult polyvalent critical care units with 40 beds, and the only oncology unit in the zone.

Patients: Critically ill patients admitted from January 2022 to June 2025 were included.

Sample: The study included all patients in the discharge database and used no sampling method.

Inclusions: All adult patients older than 18 years admitted during the study period were included.

Exclusions: The analysis excluded patients admitted as intermediate care (low therapeutic intervention with a TISS [Therapeutic Intervention Scoring System]-28 score below 20 points).

Data collection: The information of all patients admitted to the ICU was systematically collected from the clinical chart on discharge and uploaded to an electronic database in a standardized online format. The severity score was calculated within the first 24 hours of admission. Demographic characteristics, insurance, diagnosis information, APACHE II score, TISS-28 score, mechanical ventilation duration, and outcome were recorded. The outcomes evaluated were mortality (early or late), ICU length of stay, and mechanical ventilation duration.

Analysis plan: The investigators used Jamovi 2.6.44 program for the analysis, and Prism 10.6.1 or Wizard 1.9.49 for the graphics. Categorical variables are presented as frequencies and proportions; continuous variables are presented as their central tendency and dispersion, after verifying normality. The Chi-square test was selected to compare categorical variables, and the t-test or the Mann-Whitney test to compare quantitative variables. A value of p < 0.01 was chosen as statistical significance. A logistic regression analysis was performed to confirm the effect of APACHE II score on the outcome. Observed mortality rate (early or late [more than 48 hours) was compared with the expected rate (standardized or SMR). The discrimination of the score was determined by the area under the curve (AUC) of the receiver operating characteristic (ROC), with a closer value to 1 for diagnosis and type of admission.

Ethical aspects: The hospital research committee previously approved the database analysis and waived informed consent, as the study was classified as low-risk research in accordance with national regulations. The project was registered on the platform ClinicalTrials.gov in accordance with the Helsinki Declaration, including observational trials.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

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

Study Contact

Study Locations

  • Colombia
    • Meta Department
      • Villavicencio, Meta Department, Colombia, 50001
        • Recruiting
        • Hospital Departamental de Villavicencio
        • Contact:

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

Adult critically ill patients with a high need of support and intervention in the intensive care unit.

Description

Inclusion Criteria:

  • All adult patients older than 18 admitted to the intensive care unit during the study period.

Exclusion Criteria:

  • Patients admitted for intermediate care (low therapeutic intervention with a TISS [Therapeutic Intervention Scoring System] - 28 score below 20 points). Patients derived to other institutions.

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 mortality
Patients who died in the intensive care unit within the first 28 days of admission.
Other: Exposure factors
Evaluation of factors associated with mortality
ICU survivors
Patients discharged from the intensive care unit alive within the first 24 days.
Other: Exposure factors
Evaluation of factors associated with mortality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Within 28 days
Dead discharges
Within 28 days

Collaborators and Investigators

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

Sponsor

Hospital Departamental de Villavicencio

Investigators

  • Principal Investigator: Norton Perez Gutierrez, MD, Hospital Departamental de Villavicencio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 10, 2026

Primary Completion (Estimated)

December 20, 2028

Study Completion (Estimated)

December 21, 2028

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 25, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GRIVI_2025_02_UCI_MORTAL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data contains sensitive information from patients.

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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