Factor Associated With Mortality in the ICU

NCT07249749 | Not Yet Recruiting

• 1 other identifier: GRIVI_2025_02_UCI_MORTAL
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critically Ill; Intensive Care (ICU); Intensive Care Medicine; Mortality; Mortality Prediction; Mortality in Intensive Care Units

Keywords

Critically Ill; Intensive Care Unit; Mortality; Colombia

Outcome Measures

Primary Outcomes (1)

• Mortality

  Dead discharges

  Within 28 days

Study Arms (2)

ICU mortality

Patients who died in the intensive care unit within the first 28 days of admission.

Other: Exposure factors

ICU survivors

Patients discharged from the intensive care unit alive within the first 24 days.

Other: Exposure factors

Interventions

Exposure factors OTHER

Evaluation of factors associated with mortality

ICU mortality; ICU survivors

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Departamental de Villavicencio: lead

Study Sites (1)

Hospital Departamental de Villavicencio

Villavicencio, Meta Department, 50001, Colombia

Location

Related Publications (6)

• Sudarsanan S, Sivadasan P, Chandra P, Omar AS, Gaviola Atuel KL, Ulla Lone H, Ragab HO, Ehsan I, Carr CS, Pattath AR, Alkhulaifi AM, Shouman Y, Almulla A. Comparison of Four Intensive Care Scores in Predicting Outcomes After Venoarterial Extracorporeal Membrane Oxygenation: A Single-center Retrospective Study. J Cardiothorac Vasc Anesth. 2025 Jan;39(1):131-142. doi: 10.1053/j.jvca.2024.10.027. Epub 2024 Oct 22.

  PMID: 39550342 RESULT

• Li X, Yi Q, Luo Y, Wei H, Ge H, Liu H, Zhang J, Li X, Xie X, Pan P, Zhou H, Liu L, Zhou C, Zhang J, Peng L, Pu J, Yuan J, Chen X, Tang Y, Zhou H. Prediction Model of In-Hospital Death for Acute Exacerbation of Chronic Obstructive Pulmonary Disease Patients Admitted to Intensive Care Unit: The PD-ICU Score. Respiration. 2025;104(2):85-99. doi: 10.1159/000541367. Epub 2024 Sep 11.

  PMID: 39260355 RESULT

• Knaus WA, Zimmerman JE, Wagner DP, Draper EA, Lawrence DE. APACHE-acute physiology and chronic health evaluation: a physiologically based classification system. Crit Care Med. 1981 Aug;9(8):591-7. doi: 10.1097/00003246-198108000-00008.

  PMID: 7261642 RESULT

• Chlabicz M, Laguna W, Kazimierczyk R, Kazimierczyk E, Lopatowska P, Gil M, Sobkowicz B, Kaminski KA, Tycinska A. Value of APACHE II, SOFA and CardShock scoring as predictive tools for cardiogenic shock: A single-centre pilot study. ESC Heart Fail. 2024 Dec;11(6):3584-3597. doi: 10.1002/ehf2.15020. Epub 2024 Aug 13.

  PMID: 39136422 RESULT

• Liengswangwong W, Siriwannabhorn R, Leela-Amornsin S, Yuksen C, Sanguanwit P, Duangsri C, Kusonkhum N, Saelim P. Comparison of Modified Early Warning Score (MEWS), Simplified Acute Physiology Score II (SAPS II), Sequential Organ Failure Assessment (SOFA), and Acute Physiology and Chronic Health Evaluation II (APACHE II) for early prediction of septic shock in diabetic patients in Emergency Departments. BMC Emerg Med. 2024 Sep 4;24(1):161. doi: 10.1186/s12873-024-01078-8.

  PMID: 39232644 RESULT

• Tekin B, Kilic J, Taskin G, Solmaz I, Tezel O, Basgoz BB. The Comparison of scoring systems: SOFA, APACHE-II, LODS, MODS, and SAPS-II in critically ill elderly sepsis patients. J Infect Dev Ctries. 2024 Jan 31;18(1):122-130. doi: 10.3855/jidc.18526.

  PMID: 38377099 RESULT

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Norton Perez Gutierrez, MD

  Hospital Departamental de Villavicencio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Norton Perez Gutierrez, MD

CONTACT

3112517471; norton.perez@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ICU director

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: January 10, 2026
• Primary Completion (Estimated): December 20, 2028
• Study Completion (Estimated): December 21, 2028
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)