NCT07279519

Brief 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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

November 26, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

4 months

First QC Date

November 26, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

FrailtyICU MortalityGeriatric Surgery

Outcome Measures

Primary Outcomes (1)

  • 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)

    30 days after ICU admission

Secondary Outcomes (2)

  • Rate of ICU Length of Stay in Geriatric Postoperative Patients

    From ICU admission to ICU discharge (up to 28 days)

  • Association Between Laboratory Markers and Frailty Scores

    At ICU admission

Study Arms (1)

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.

Eligibility Criteria

Age65 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Eğitim Araştırma Hastanesi

Malatya, 44000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

MeSH Terms

Conditions

Postoperative ComplicationsFrailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Leman Acun Delen, MD, Assoc. Prof.

    Malatya Training and Research Hospital, Department of Anesthesiology and Intensive Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Leman Acun Delen, Assoc. Prof. of Anesthesiology

CONTACT

Leman acun delen, MD, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Anesthesiology and İntensive Care

Study Record Dates

First Submitted

November 26, 2025

First Posted

December 12, 2025

Study Start

January 15, 2026

Primary Completion

April 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

December 12, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

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.

Locations