Postoperative MortalityGERI-MORTALNCT07279519
Predictive Value of Frailty Scores and Admission Laboratory Markers for Postoperative ICU Mortality
An observational study of Postoperative Mortality and Frailty at Older Adults, run by Malatya Egitim Ve Arastirma Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the predictive value of the Clinical Frailty Scale (CFS), the Katz Activities of Daily Living (ADL) scale, and admission laboratory markers for postoperative mortality among geriatric patients admitted to the intensive care unit (ICU) after surgery. Read more about this study
- Who is it for?
- Ages 65 to 65 years
- Conditions the study is for
- Postoperative Mortality, Frailty at Older Adults, Activities of Daily Living
- How many people
- 393 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 15 Apr 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 65 to 65 years
- All sexes
- No healthy volunteers
- Older adult
Study population: This study will include geriatric patients aged 65 years and older who have undergone elective or emergency surgery and require postoperative monitoring in the intensive care unit for at least 24 hours. Patients must provide informed consent personally or through a legally authorized representative
Who may be able to join
- Individuals aged 65 years and older Undergoing elective or emergency surgery Monitored in the intensive care unit for at least 24 hours after surgery Provision of informed consent by the patient or the legal representative
Who cannot join
- Patients with incomplete or unavailable data sets ICU stays shorter than 24 hours Patients admitted for organ transplantation or those in the terminal stage receiving palliative care
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Malatya Eğitim Araştırma Hastanesi
Malatya, 44000
About this study
Official title: Predictive Value of the Clinical Frailty Scale, Katz ADL, and Admission Laboratory Markers for Postoperative ICU Mortality in Geriatric Patients: A Prospective Observational Study
This prospective observational study aims to evaluate the predictive value of the Clinical Frailty Scale (CFS), the Katz Activities of Daily Living (ADL) scale, and admission laboratory markers for postoperative mortality among geriatric patients admitted to the intensive care unit (ICU) after surgery. Frailty assessment and functional status are increasingly recognized as determinants of outcomes in older adults, yet their combined predictive power with routine laboratory parameters at ICU admission remains unclear. By systematically collecting clinical scores and laboratory data at the time of ICU admission, this study seeks to identify early predictors of mortality and support risk-stratification in geriatric postoperative patients.
Read the detailed description
This prospective observational study aims to evaluate the predictive value of the Clinical Frailty Scale (CFS), Katz Activities of Daily Living (ADL) score, and admission laboratory markers for postoperative ICU mortality in geriatric patients. Frailty and functional dependency are known to influence postoperative outcomes; however, their combined role alongside early biochemical indicators at the time of ICU admission has not been well defined in this population.
In this study, patients aged 65 years and older who are admitted to the intensive care unit following surgery will be assessed using the CFS and Katz ADL scores within the first hours of ICU admission. Laboratory data obtained at the time of admission-including complete blood count, renal and hepatic panels, electrolytes, markers of inflammation, and arterial blood gas parameters-will be recorded. Patients will subsequently be followed throughout their ICU stay to document clinical course and outcomes, with ICU mortality designated as the primary endpoint.
The goal of this research is to identify which frailty indicators and laboratory markers are independently associated with mortality, and to explore whether combining functional status scores with early laboratory abnormalities improves risk stratification in geriatric postoperative ICU patients. The findings may support the development of simple, bedside-applicable tools for early mortality prediction and clinical decision-making in this high-risk population.
- Conditions
- Postoperative Mortality, Frailty at Older Adults, Activities of Daily Living, Postoperative Complications
- Keywords
- Frailty, ICU Mortality, Geriatric Surgery
- Medical subject headings
- Postoperative Complications, Frailty
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 |
|---|---|---|
| Geriatric Postoperative ICU Cohort | This cohort includes geriatric patients (≥65 years) admitted to the intensive care unit after surgery. All participants are followed prospectively to evaluate clinical frailty, functional status, and admission laboratory parameters in relation to postoperative ICU mortality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day ICU Mortality
Mortality status will be determined at the time of ICU discharge. Mortality is defined as all-cause death occurring during the postoperative ICU stay. Data will be collected prospectively from the electronic medical record and verified by the ICU clinical team. The outcome will be recorded as a binary variable (survived / died)
Measured: 30 days after ICU admission
Secondary outcomes (2)
Rate of ICU Length of Stay in Geriatric Postoperative Patients
Duration of stay in the intensive care unit, recorded in days. Longer ICU stay is often associated with increased frailty, limited functional capacity, and higher physiological burden. This variable will be extracted from the clinical records and analyzed in relation to frailty, Katz ADL score, and admission laboratory markers.
Measured: From ICU admission to ICU discharge (up to 28 days)
Association Between Laboratory Markers and Frailty Scores
Correlation analysis between baseline laboratory parameters (e.g., hemoglobin, creatinine, CRP, albumin) and frailty assessments (Clinical Frailty Scale and Katz ADL).
Measured: At ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start1 Sep 2025
- Primary completion1 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative MortalityStudies 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
- Prospective
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malatya Egitim Ve Arastirma Hastanesi
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Leman Acun Delen, Malatya Egitim Ve Arastirma Hastanesi
- Investigators
- Leman Acun Delen, MD, Assoc. Prof., Principal investigator, Malatya Training and Research Hospital, Department of Anesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279519
- Sponsor's protocol ID
- MEAH-GER-ICU-2025-01
- Acronym
- GERI-MORTAL
- Status last verified
- May 2026
- First submitted
- 26 Nov 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to institutional policies, patient privacy concerns, and local ethical regulations, individual-level clinical data cannot be shared publicly. Only aggregated and anonymized results will be reported.
Publications
Hanci P, Temel E, Bilir F, Kaya BS. Lactate to albumin ratio as a determinant of intensive care unit admission and mortality in hospitalized patients with community-acquired pneumonia. BMC Pulm Med. 2025 May 9;25(1):224. doi: 10.1186/s12890-025-03698-7.
PubMed 40346545Moisi L, Mino JC, Guidet B, Vallet H. Frailty assessment in critically ill older adults: a narrative review. Ann Intensive Care. 2024 Jun 18;14(1):93. doi: 10.1186/s13613-024-01315-0.
PubMed 38888743Chen W, Chen M, Qiao X. Interaction of lactate/albumin and geriatric nutritional risk index on the all-cause mortality of elderly patients with critically ill heart failure: A cohort study. Clin Cardiol. 2023 Jul;46(7):745-756. doi: 10.1002/clc.24029. Epub 2023 May 24.
PubMed 37226575
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of the Clinical Frailty Scale, Katz ADL, and Admission Laboratory Markers for Postoperative ICU Mortality in Geriatric Patients: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07279519
- Acronym / sponsor ID
- GERI-MORTAL / MEAH-GER-ICU-2025-01
- Conditions
- Postoperative Mortality, Frailty at Older Adults, Activities of Daily Living, Postoperative Complications
- Keywords
- Frailty, ICU Mortality, Geriatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- Malatya Egitim Ve Arastirma HastanesiOther government
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 12 Dec 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.
This prospective observational study aims to evaluate the predictive value of the Clinical Frailty Scale (CFS), the Katz Activities of Daily Living (ADL) scale, and admission laboratory markers for postoperative mortality among geriatric patients admitted to the intensive care unit (ICU) after surgery. Frailty assessment and functional status are increasingly recognized as determinants of outcomes in older adults, yet their combined predictive power with routine laboratory parameters at ICU admission remains unclear. By systematically collecting clinical scores and laboratory data at the time of ICU admission, this study seeks to identify early predictors of mortality and support risk-stratification in geriatric postoperative patients.
Detailed description
This prospective observational study aims to evaluate the predictive value of the Clinical Frailty Scale (CFS), Katz Activities of Daily Living (ADL) score, and admission laboratory markers for postoperative ICU mortality in geriatric patients. Frailty and functional dependency are known to influence postoperative outcomes; however, their combined role alongside early biochemical indicators at the time of ICU admission has not been well defined in this population.
In this study, patients aged 65 years and older who are admitted to the intensive care unit following surgery will be assessed using the CFS and Katz ADL scores within the first hours of ICU admission. Laboratory data obtained at the time of admission-including complete blood count, renal and hepatic panels, electrolytes, markers of inflammation, and arterial blood gas parameters-will be recorded. Patients will subsequently be followed throughout their ICU stay to document clinical course and outcomes, with ICU mortality designated as the primary endpoint.
The goal of this research is to identify which frailty indicators and laboratory markers are independently associated with mortality, and to explore whether combining functional status scores with early laboratory abnormalities improves risk stratification in geriatric postoperative ICU patients. The findings may support the development of simple, bedside-applicable tools for early mortality prediction and clinical decision-making in this high-risk population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric Postoperative ICU Cohort | – | –This cohort includes geriatric patients (≥65 years) admitted to the intensive care unit after surgery. All participants are followed prospectively to evaluate clinical frailty, functional status, and admission laboratory parameters in relation to postoperative ICU mortality. |
Who may qualify
- Ages
- 65 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- This study will include geriatric patients aged 65 years and older who have undergone elective or emergency surgery and require postoperative monitoring in the intensive care unit for at least 24 hours. Patients must provide informed consent personally or through a legally authorized representative
Key inclusion criteria (1 listed)
- Individuals aged 65 years and older Undergoing elective or emergency surgery Monitored in the intensive care unit for at least 24 hours after surgery Provision of informed consent by the patient or the legal representative
Key exclusion criteria (1 listed)
- Patients with incomplete or unavailable data sets ICU stays shorter than 24 hours Patients admitted for organ transplantation or those in the terminal stage receiving palliative care
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
30-day ICU Mortality
Time frame: 30 days after ICU admission
Mortality status will be determined at the time of ICU discharge. Mortality is defined as all-cause death occurring during the postoperative ICU stay. Data will be collected prospectively from the electronic medical record and verified by the ICU clinical team. The outcome will be recorded as a binary variable (survived / died)
2 secondary outcomes
Rate of ICU Length of Stay in Geriatric Postoperative Patients
Time frame: From ICU admission to ICU discharge (up to 28 days)
Association Between Laboratory Markers and Frailty Scores
Time frame: At ICU admission
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 8 Oct 2026.
- Results publication: PubMed 40346545Hanci P, Temel E, Bilir F, Kaya BS. Lactate to albumin ratio as a determinant of intensive care unit admission and mortality in hospitalized patients with community-acquired pneumonia. BMC Pulm Med. 2025 May 9;25(1):224. doi: 10.1186/s12890-025-03698-7.
- Results publication: PubMed 38888743Moisi L, Mino JC, Guidet B, Vallet H. Frailty assessment in critically ill older adults: a narrative review. Ann Intensive Care. 2024 Jun 18;14(1):93. doi: 10.1186/s13613-024-01315-0.
- Results publication: PubMed 37226575Chen W, Chen M, Qiao X. Interaction of lactate/albumin and geriatric nutritional risk index on the all-cause mortality of elderly patients with critically ill heart failure: A cohort study. Clin Cardiol. 2023 Jul;46(7):745-756. doi: 10.1002/clc.24029. Epub 2023 May 24.
- Individual participant dataSharing planned: No. Due to institutional policies, patient privacy concerns, and local ethical regulations, individual-level clinical data cannot be shared publicly. Only aggregated and anonymized results will be reported.
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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. This study is not recruiting at the moment.
Leman Acun Delen, MD, Assoc. Prof. principal investigator
Malatya Training and Research Hospital, Department of Anesthesiology and Intensive Care
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 Postoperative Mortality and Frailty at Older Adults, run by Malatya Egitim Ve Arastirma Hastanesi 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 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: finished, as of the sponsor's last update on 8 Oct 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?
30-day ICU Mortality (time frame: 30 days after ICU admission). 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 NCT07279519, which also lists 3 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 8 Oct 2026.