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临床试验/NCT07683260
NCT07683260已完成不适用

Prognostic Value of Systemic Immune-Inflammatory and Nutritional Indices for Mortality and Morbidity in Acute Aortic Dissection: A Single-Center Retrospective Study

Bursa City Hospital1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2026年6月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
127
试验地点
1
主要终点
in-hospital mortality

研究概览

简要总结

Identifying early on which patients with acute aortic dissection require closer monitoring may help with care planning. If simple, inexpensive values obtained from routine blood tests can provide additional information for assessing risk, this knowledge could in the future help physicians follow their patients more effectively. The aim of this study is to investigate this possibility scientifically.

It is based on the evaluation of information obtained from blood tests that are already being performed. Its purpose is to generate general knowledge that may contribute to the care of future patients. The study itself does not change decisions about your treatment; all decisions regarding your treatment and follow-up rest with your doctor, who evaluates your condition in its entirety.

It is designed to evaluate the relationship between preoperative/postoperative systemic immune-inflammatory and nutritional markers (SII, NLR, PLR, CAR, PNI) and indicators of mortality and morbidity (length of stay and changes in kidney function) in patients with acute aortic dissection. The goal is to investigate the potential of easily accessible laboratory parameters to contribute to risk stratification. The relationship between the markers and outcomes will be analyzed using appropriate statistical methods.

This study is based on the evaluation of information in patients' existing medical records and blood tests. The data are processed in accordance with the relevant ethical rules and privacy principles, with patient identity kept confidential. Taking part in the study does not require any additional procedure, additional blood draw, or change in treatment.

详细描述

This is a single-center observational study based on a retrospective review of the records of patients who underwent surgical treatment for acute aortic dissection at the Bursa City Hospital Operating Room between January 1, 2022, and March 1, 2026. The study was planned and conducted in accordance with the principles of the Declaration of Helsinki and was approved by the Bursa City Hospital Scientific Research Ethics Committee (Decision No: 2026-12/9).

A total of 127 adult patients who underwent surgical treatment with a diagnosis of acute aortic dissection during the specified period were included in the study. The diagnosis was confirmed through clinical findings and radiological examinations, primarily computed tomography angiography, and the type of dissection was recorded. Inclusion criteria: being 18 years of age or older and having undergone surgical intervention for acute aortic dissection. Patients meeting the following criteria were excluded from the study: those with a diagnosis of chronic aortic dissection; cases with missing preoperative laboratory data or clinical outcome records; patients with hematological malignancies or disorders such as leukemia, lymphoma, or immune thrombocytopenic purpura (ITP); those with chronic inflammatory or autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus (SLE), or ankylosing spondylitis; patients with active steroid use, immunosuppressive therapy, or recent chemotherapy; and those diagnosed with decompensated liver failure or end-stage renal disease (ESRD). These exclusion criteria were established to ensure the reliability of the results by eliminating patients with comorbidities or treatments that could directly affect neutrophil, platelet, and lymphocyte counts-the study's primary independent variables.

All data were obtained from the hospital's electronic information system and patient files. Age, gender, dissection type, and left ventricular ejection fraction were recorded as demographic and clinical variables. Preoperative blood values were recorded prior to the surgical intervention. The preoperative laboratory parameters examined included white blood cell (WBC) count, neutrophil, lymphocyte, and platelet counts, hemoglobin, D-dimer, creatine kinase-MB (CK-MB), troponin, creatinine, estimated glomerular filtration rate (eGFR), albumin, and C-reactive protein (CRP) levels. Lactate, partial pressure of carbon dioxide (pCO2), and partial pressure of oxygen (pO2) values were obtained from preoperative arterial blood gas analysis. In surviving patients, postoperative values for the same markers were also calculated.

The composite markers investigated were calculated for each patient using the following formulas based on preoperative laboratory values:

Systemic Immune-Inflammation Index (SII): (neutrophil count × platelet count) / lymphocyte count Neutrophil-to-Lymphocyte Ratio (NLR): neutrophil count / lymphocyte count Platelet-to-Lymphocyte Ratio (PLR): platelet count / lymphocyte count CRP-to-Albumin Ratio (CAR): CRP / albumin Prognostic Nutritional Index (PNI): (10 × serum albumin [g/dL]) + (0.005 × total lymphocyte count [/mm3]) SII × Lactate Composite Index: SII × preoperative arterial lactate (mmol/L) The SII × Lactate composite index was defined to combine systemic inflammatory load (SII) and tissue hypoperfusion/anaerobic metabolism (lactate) into a single value. In surviving patients, postoperative values of SII, NLR, PLR, CAR, and PNI were also calculated using the same formulas and compared with preoperative values.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of acute aortic dissection (ICD-10 code I71.0) in the emergency department
  • Underwent surgical repair for acute aortic dissection under the specified surgical codes

排除标准

  • Diagnosed with acute aortic dissection (ICD-10 code I71.0) in the emergency department but did not undergo surgery
  • Hematologic disease (e.g., leukemia, lymphoma, idiopathic thrombocytopenic purpura)
  • Chronic inflammatory or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis)
  • Chronic steroid use, immunosuppressive therapy, or recent chemotherapy
  • Liver failure (affects platelet production and coagulation factors)
  • End-stage renal disease requiring hemodialysis
  • Missing result in any of the neutrophil, lymphocyte, or platelet blood tests

结局指标

主要结局

in-hospital mortality

时间窗: From the date of surgery until the date of hospital discharge, assessed up to 100 days.

These are deaths not related to aortic dissection that occur after surgery in patients who have not yet been discharged from the hospital but have been transferred to another clinic for a different reason.

Perioperative exitus

时间窗: the period from the patient's surgery up to the 30th day

It refers to the patients in whom perioperative death occurred among those who underwent surgery for acute aortic dissection.These are the patients who died due to aortic dissection after surgery, before being discharged from the hospital and without being transferred to another clinic for a different reason.

次要结局

  • intensive care unit and hospital length of stay(From the date of surgery until the date of intensive care unit discharge, assessed up to 100 days)
  • development of renal failure(the period from the patient's surgery up to the 3rd month)
  • intraoperative and postoperative use of blood products(from the time of surgery up to 24 hours thereafter)

研究者

发起方
Bursa City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

eralp çevikkalp

Associate Professor

Bursa City Hospital

研究点 (1)

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