Critically IllICUMortalNCT07249749
Factor Associated With Mortality in the ICU
An observational study of Critically Ill and Intensive Care (ICU), run by Hospital Departamental de Villavicencio at 1 site in Colombia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Critically Ill, Intensive Care (ICU), Intensive Care Medicine
- What is being tested?
- Exposure factors
- How many people
- 1,000 participants
- Where
- 1 siteColombia
- Study dates
- 10 Jan 2026to 21 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult critically ill patients with a high need of support and intervention in the intensive care unit.
Who may be able to join
- All adult patients older than 18 admitted to the intensive care unit during the study period.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
Hospital Departamental de Villavicencio
Villavicencio, Meta Department, 50001
Norton Perez Gutierrez, MD, 3112517471, norton.perez@hotmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Critically Ill, Intensive Care (ICU), Intensive Care Medicine, Mortality, Mortality Prediction, Mortality in Intensive Care Units
- Being tested
- Exposure factors
- Keywords
- Critically Ill, Intensive Care Unit, Mortality, Colombia
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure factorsOther
Evaluation of factors associated with mortality
| Study group | Role | What they receive |
|---|---|---|
| ICU mortality | Patients who died in the intensive care unit within the first 28 days of admission. Receives: Other: Exposure factors | |
| ICU survivors | Patients discharged from the intensive care unit alive within the first 24 days. Receives: Other: Exposure factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Dead discharges
Measured: Within 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start10 Jan 2026
- Primary completion20 Dec 2028 (estimated)
- Study completion21 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies 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
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Departamental de Villavicencio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norton Perez-Gutierrez, MD, Hospital Departamental de Villavicencio
- Investigators
- Norton Perez Gutierrez, MD, Principal investigator, Hospital Departamental de Villavicencio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07249749
- Sponsor's protocol ID
- GRIVI_2025_02_UCI_MORTAL
- Acronym
- ICUMortal
- Status last verified
- May 2026
- First submitted
- 18 Nov 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data contains sensitive information from patients.
Publications
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.
PubMed 39550342Li 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.
PubMed 39260355Knaus 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.
PubMed 7261642Chlabicz 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.
PubMed 39136422Liengswangwong 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.
PubMed 39232644Tekin 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.
PubMed 38377099
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Mortality in the Intensive Care Unit From the Orinoco Region. An Observational Trial
- ClinicalTrials.gov ID
- NCT07249749
- Acronym / sponsor ID
- ICUMortal / GRIVI_2025_02_UCI_MORTAL
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hospital Departamental de VillavicencioUniversity, hospital or other
- Study start
- 10 Jan 2026 (actual)
- Primary completion
- 20 Dec 2028 (estimated)
- Study completion
- 21 Dec 2028 (estimated)
- First posted
- 25 Nov 2025 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICU mortality | – | Other: Exposure factorsPatients who died in the intensive care unit within the first 28 days of admission. |
| ICU survivors | – | Other: Exposure factorsPatients discharged from the intensive care unit alive within the first 24 days. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients with a high need of support and intervention in the intensive care unit.
Key inclusion criteria (1 listed)
- All adult patients older than 18 admitted to the intensive care unit during the study period.
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Exposure factorsEvaluation of factors associated with mortality | Other | ICU mortality, ICU survivors |
Primary outcome
Mortality
Time frame: Within 28 days
Dead discharges
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Results publication: PubMed 39550342Sudarsanan 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.
- Results publication: PubMed 39260355Li 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.
- Results publication: PubMed 7261642Knaus 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.
- Results publication: PubMed 39136422Chlabicz 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.
- Results publication: PubMed 39232644Liengswangwong 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.
- Results publication: PubMed 38377099Tekin 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.
- Individual participant dataSharing planned: No. The data contains sensitive information from patients.
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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.
Norton Perez Gutierrez, MD principal investigator
Hospital Departamental de Villavicencio
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 Critically Ill and Intensive Care (ICU), run by Hospital Departamental de Villavicencio at 1 site in Colombia.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 May 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 Colombia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norton Perez Gutierrez, MD (3112517471, norton.perez@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Within 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07249749, which also lists 6 linked publications.
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 27 May 2026.