- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07279519
Predictive Value of Frailty Scores and Admission Laboratory Markers for Postoperative ICU Mortality (GERI-MORTAL)
Predictive Value of the Clinical Frailty Scale, Katz ADL, and Admission Laboratory Markers for Postoperative ICU Mortality in Geriatric Patients: A Prospective Observational Study
Study Overview
Status
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Malatya, Turkey (Türkiye), 44000
- Malatya Eğitim Araştırma Hastanesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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30-day ICU Mortality
Time Frame: 30 days after ICU admission
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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)
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30 days after ICU admission
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Rate of ICU Length of Stay in Geriatric Postoperative Patients
Time Frame: From ICU admission to ICU discharge (up to 28 days)
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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.
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From ICU admission to ICU discharge (up to 28 days)
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Association Between Laboratory Markers and Frailty Scores
Time Frame: At ICU admission
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Correlation analysis between baseline laboratory parameters (e.g., hemoglobin, creatinine, CRP, albumin) and frailty assessments (Clinical Frailty Scale and Katz ADL).
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At ICU admission
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Collaborators and Investigators
Investigators
- Principal Investigator: Leman Acun Delen, MD, Assoc. Prof., Malatya Training and Research Hospital, Department of Anesthesiology and Intensive Care
Publications and helpful links
General Publications
- Moisi 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.
- Chen 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEAH-GER-ICU-2025-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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