NCT07544719

Brief Summary

The Systemic Immuno-Inflammation Index (SII) is a ratio derived from complete blood count parameters (neutrophils, lymphocytes, platelets) and is a non-invasive and easily calculable biomarker. The SIPI effectively reflects both local and systemic inflammatory responses in the human body. It has been used to predict and evaluate the prognosis of various solid tumors such as gastric cancer, non-small cell lung cancer, and colorectal cancer. Furthermore, the SIPI has been shown to have significant prognostic value in cardiovascular and cerebrovascular diseases. In this study, the SIPI will be calculated using laboratory data at the time of admission to the intensive care unit, and the relationship between the obtained values and the 30-day mortality status of the patients will be analyzed.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jun 2026

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

April 9, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 22, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 15, 2026

Expected
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

April 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

April 9, 2026

Last Update Submit

April 18, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measuring the Systemic Immune-Inflammation Index (SII) in postoperative patients to see the parameter's predictibility of 30-day mortality

    In geriatric patients admitted to the intensive care unit after surgery, the Systemic Immune-Inflammation Index (SII) is a significant biomarker for predicting 30-day mortality.

    Postoperative day 1

Eligibility Criteria

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

65 years of age or older postoperative patients

You may qualify if:

  • The patient must be 65 years of age or older (in the geriatric age group),
  • Admitted to the intensive care unit after elective or emergency surgery
  • Have access to complete blood count (hemogram) data (neutrophils, lymphocytes, platelets) during their stay in the intensive care unit
  • Be able to undergo 30-day mortality monitoring from the date of admission to the intensive care unit
  • Have provided informed consent from the patient or their legal representative.

You may not qualify if:

  • Patients under 65 years of age
  • Patients admitted to the intensive care unit for non-surgical reasons (e.g., trauma, medical intensive care indications)
  • Patients with deficient neutrophil, lymphocyte, or platelet counts upon admission to the intensive care unit
  • Patients with a history of malignancy, hematological disease, or immunosuppressive therapy
  • Terminally ill palliative patients
  • Patients who refuse informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Chen JH, Zhai ET, Yuan YJ, Wu KM, Xu JB, Peng JJ, Chen CQ, He YL, Cai SR. Systemic immune-inflammation index for predicting prognosis of colorectal cancer. World J Gastroenterol. 2017 Sep 14;23(34):6261-6272. doi: 10.3748/wjg.v23.i34.6261.

  • Zeng QY, Qin Y, Shi Y, Mu XY, Huang SJ, Yang YH, Liu SM, An ZM, Li SQ. Systemic immune-inflammation index and all-cause and cause-specific mortality in sarcopenia: a study from National Health and Nutrition Examination Survey 1999-2018. Front Immunol. 2024 Apr 4;15:1376544. doi: 10.3389/fimmu.2024.1376544. eCollection 2024.

Central Study Contacts

Ayşe Yılkınç Tekirdaş

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 22, 2026

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

April 22, 2026

Record last verified: 2026-01