Critical IllnessNCT07369206
ICU Admission Diagnoses and ICU Mortality
An observational study of Critical Illness and Sepsis, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective cohort study will evaluate whether syndromic clinical diagnoses present at ICU admission are associated with ICU mortality, independent of physiologic severity scores. Adult patients admitted to a tertiary mixed ICU during 2025 will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Sepsis, Septic Shock
- How many people
- 1,248 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2026to 2 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the tertiary mixed ICU of Atatürk University Faculty of Medicine (Department of Anesthesiology and Reanimation) between January 1 2024 and December 31 2025. Data will be collected retrospectively from hospital information systems and ICU records, based on the first 24 hours after ICU admission.
Who may be able to join
- Adult patients (≥18 years) admitted to the ICU between January 1, 2025 and December 31, 2025.
- If a patient has more than one ICU admission during the study period, only the first ICU admission will be included.
Who cannot join
- ICU stay <24 hours.
- Missing essential data preventing assessment of the primary outcome (ICU mortality) and/or calculation of severity scores (APACHE II, SAPS, SOFA).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Admission Syndromic Diagnoses With ICU Mortality in a Mixed Adult Intensive Care Unit: Retrospective Cohort
This retrospective cohort study will evaluate whether syndromic clinical diagnoses present at ICU admission are associated with ICU mortality, independent of physiologic severity scores. Adult patients admitted to a tertiary mixed ICU during 2025 will be assessed.
Read the detailed description
Data will be obtained retrospectively from the hospital information system and ICU clinical records. Variables will be recorded based on the first 24 hours after ICU admission. Demographics, admission characteristics, comorbidities, severity scores (APACHE II, SAPS, SOFA), and admission syndromic diagnoses (e.g., sepsis/septic shock, acute respiratory failure, ARDS, MODS) will be collected. The primary outcome is ICU mortality; secondary outcomes include ICU length of stay and ICU discharge disposition.
- Conditions
- Critical Illness, Sepsis, Septic Shock, Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure, Multiple Organ Dysfunction Syndrome
- Keywords
- Intensive Care Unit, ICU Mortality, Admission Diagnosis, Retrospective Cohort, Severity Score, APACHE II, SAPS, SOFA, Length of Stay
- Medical subject headings
- Critical Illness, Sepsis, Shock, Septic, Respiratory Distress Syndrome, Multiple Organ Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult ICU admissions (2025) | Adult patients (≥18 years) admitted to a tertiary mixed intensive care unit between January 1, 2025 and December 31, 2025. For patients with multiple ICU admissions, only the first ICU admission will be included. Data will be abstracted retrospectively from electronic medical records and ICU charts; variables will be recorded based on the first 24 hours after ICU admission. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Death occurring during the index ICU stay (ICU mortality), abstracted from electronic medical records.
Measured: From ICU admission until ICU discharge (end of index ICU stay), assessed up to 90 days
Secondary outcomes (2)
ICU length of stay (LOS)
ICU length of stay (days) during the index ICU admission, calculated as the difference between ICU admission and ICU discharge timestamps in the electronic medical record.
Measured: From ICU admission to ICU discharge (index ICU stay), assessed at ICU discharge (up to 90 days)
ICU discharge disposition
Disposition at ICU discharge categorized as: death in ICU, transfer to hospital ward, or transfer to another facility; determined from the ICU discharge documentation in the electronic medical record.
Measured: At ICU discharge (index ICU stay; assessed at the time of ICU discharge in the medical record, up to 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start30 Jan 2026
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- 1,248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Akif Yilmaz, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369206
- Sponsor's protocol ID
- ICU-RETRO-2025
- Other IDs
- 2026/1
- Status last verified
- Feb 2026
- First submitted
- 8 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the dataset is derived from retrospective hospital records and contains potentially identifiable information.
Publications
Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. doi: 10.1001/jama.270.24.2957.
PubMed 8254858Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
PubMed 3928249Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Nov 21;369(21):2063. doi: 10.1056/NEJMc1312359. No abstract available.
PubMed 24256390Vincent JL, Marshall JC, Namendys-Silva SA, Francois B, Martin-Loeches I, Lipman J, Reinhart K, Antonelli M, Pickkers P, Njimi H, Jimenez E, Sakr Y; ICON investigators. Assessment of the worldwide burden of critical illness: the intensive care over nations (ICON) audit. Lancet Respir Med. 2014 May;2(5):380-6. doi: 10.1016/S2213-2600(14)70061-X. Epub 2014 Apr 14.
PubMed 24740011
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Admission Syndromic Diagnoses With ICU Mortality in a Mixed Adult Intensive Care Unit: Retrospective Cohort
- ClinicalTrials.gov ID
- NCT07369206
- Acronym / sponsor ID
- ICU-RETRO-2025
- Conditions
- Critical Illness, Sepsis, Septic Shock, Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure, Multiple Organ Dysfunction Syndrome
- Keywords
- Intensive Care Unit, ICU Mortality, Admission Diagnosis, Retrospective Cohort, Severity Score, APACHE II, SAPS, SOFA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,248 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 27 Jan 2026 (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.
This retrospective cohort study will evaluate whether syndromic clinical diagnoses present at ICU admission are associated with ICU mortality, independent of physiologic severity scores. Adult patients admitted to a tertiary mixed ICU during 2025 will be assessed.
Detailed description
Data will be obtained retrospectively from the hospital information system and ICU clinical records. Variables will be recorded based on the first 24 hours after ICU admission. Demographics, admission characteristics, comorbidities, severity scores (APACHE II, SAPS, SOFA), and admission syndromic diagnoses (e.g., sepsis/septic shock, acute respiratory failure, ARDS, MODS) will be collected. The primary outcome is ICU mortality; secondary outcomes include ICU length of stay and ICU discharge disposition.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult ICU admissions (2025) | – | –Adult patients (≥18 years) admitted to a tertiary mixed intensive care unit between January 1, 2025 and December 31, 2025. For patients with multiple ICU admissions, only the first ICU admission will be included. Data will be abstracted retrospectively from electronic medical records and ICU charts; variables will be recorded based on the first 24 hours after ICU admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the tertiary mixed ICU of Atatürk University Faculty of Medicine (Department of Anesthesiology and Reanimation) between January 1 2024 and December 31 2025. Data will be collected retrospectively from hospital information systems and ICU records, based on the first 24 hours after ICU admission.
Key inclusion criteria (2 listed)
- Adult patients (≥18 years) admitted to the ICU between January 1, 2025 and December 31, 2025.
- If a patient has more than one ICU admission during the study period, only the first ICU admission will be included.
Key exclusion criteria (2 listed)
- ICU stay <24 hours.
- Missing essential data preventing assessment of the primary outcome (ICU mortality) and/or calculation of severity scores (APACHE II, SAPS, SOFA).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU mortality
Time frame: From ICU admission until ICU discharge (end of index ICU stay), assessed up to 90 days
Death occurring during the index ICU stay (ICU mortality), abstracted from electronic medical records.
2 secondary outcomes
ICU length of stay (LOS)
Time frame: From ICU admission to ICU discharge (index ICU stay), assessed at ICU discharge (up to 90 days)
ICU discharge disposition
Time frame: At ICU discharge (index ICU stay; assessed at the time of ICU discharge in the medical record, up to 90 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 8254858Le Gall JR, Lemeshow S, Saulnier F. A new Simplified Acute Physiology Score (SAPS II) based on a European/North American multicenter study. JAMA. 1993 Dec 22-29;270(24):2957-63. doi: 10.1001/jama.270.24.2957.
- Background: PubMed 3928249Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985 Oct;13(10):818-29.
- Background: PubMed 24256390Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Nov 21;369(21):2063. doi: 10.1056/NEJMc1312359. No abstract available.
- Background: PubMed 24740011Vincent JL, Marshall JC, Namendys-Silva SA, Francois B, Martin-Loeches I, Lipman J, Reinhart K, Antonelli M, Pickkers P, Njimi H, Jimenez E, Sakr Y; ICON investigators. Assessment of the worldwide burden of critical illness: the intensive care over nations (ICON) audit. Lancet Respir Med. 2014 May;2(5):380-6. doi: 10.1016/S2213-2600(14)70061-X. Epub 2014 Apr 14.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the dataset is derived from retrospective hospital records and contains potentially identifiable information.
Related trials for Critical Illness
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Recruiting
Development and Preliminary Validation of Intelligent Video Laryngoscope for Emergency Use
Critically Ill Patients Requiring Mechanical Ventilation
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Core Competencies in General Intensive Care Ultrasound (GenIUS): a Delphi Study
Critical Illness, Ultrasound
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Critical Illness and Sepsis, run by Ataturk University at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 4 Feb 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: From ICU admission until ICU discharge (end of index ICU stay), assessed up to 90 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 NCT07369206, which also lists 4 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 4 Feb 2026.