- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07544719
Systemic Immun Inflamation Score Corelation in Postoperative Patients Prognosis
April 18, 2026 updated by: Leman Acun Delen, Malatya Egitim Ve Arastirma Hastanesi
Prognostic Value of Systemic Immun Inflamation Index in Geriatrik Patient Admitted to the ICU After Surgery: A Prospective Observational Study
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ayşe Yılkınç Tekirdaş
- Phone Number: +905395721741
- Email: ylknc.ys.44@hotmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
65 years of age or older postoperative patients
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring the Systemic Immune-Inflammation Index (SII) in postoperative patients to see the parameter's predictibility of 30-day mortality
Time Frame: Postoperative day 1
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 15, 2026
Primary Completion (Estimated)
July 15, 2026
Study Completion (Estimated)
July 30, 2026
Study Registration Dates
First Submitted
April 9, 2026
First Submitted That Met QC Criteria
April 18, 2026
First Posted (Actual)
April 22, 2026
Study Record Updates
Last Update Posted (Actual)
April 22, 2026
Last Update Submitted That Met QC Criteria
April 18, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- MEAH-SII-ICU-2026-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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