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Immune-Inflammatory Markers in Aortic Dissection

27 de junio de 2026 actualizado por: eralp çevikkalp, Bursa City Hospital

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

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.

Descripción general del estudio

Descripción detallada

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.

The primary outcomes of the study were perioperative exitus and in-hospital mortality. Secondary outcomes included length of stay in the intensive care unit and hospital, the development of renal failure in surviving patients, and intraoperative and postoperative blood product usage. Renal failure was evaluated using two separate definitions: (i) eGFR falling below 60 mL/min/1.73 m² at the 1st and/or 3rd postoperative month; (ii) the ratio of the 1st and/or 3rd month postoperative creatinine to preoperative creatinine being greater than 1.5. Renal function parameters during the follow-up period were evaluated only in surviving patients.

Tipo de estudio

De observación

Inscripción (Actual)

127

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra de probabilidad

Población de estudio

Patients who underwent surgery for acute aortic dissection in the operating room of Bursa City Hospital

Descripción

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Patients who underwent surgery due to aortic dissection
The diagnosis was confirmed by clinical findings and radiological examinations, primarily computed tomography angiography, and the dissection type was recorded. Inclusion criteria were being 18 years of age or older and having undergone surgical intervention for acute aortic dissection.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
in-hospital mortality
Periodo de tiempo: 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.
From the date of surgery until the date of hospital discharge, assessed up to 100 days.
Perioperative exitus
Periodo de tiempo: 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.
the period from the patient's surgery up to the 30th day

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
intensive care unit and hospital length of stay
Periodo de tiempo: From the date of surgery until the date of intensive care unit discharge, assessed up to 100 days
to investigate its effect on the length of stay in the intensive care unit and in the hospital in surviving patients.
From the date of surgery until the date of intensive care unit discharge, assessed up to 100 days
development of renal failure
Periodo de tiempo: the period from the patient's surgery up to the 3rd month
to investigate its effect on the development of renal failure at the 1st and 3rd months in surviving patients.
the period from the patient's surgery up to the 3rd month
intraoperative and postoperative use of blood products
Periodo de tiempo: from the time of surgery up to 24 hours thereafter
The effect of immune-inflammatory indices on intraoperative and postoperative use of blood products will be investigated
from the time of surgery up to 24 hours thereafter

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: esat demirel, MD, Bursa City Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

18 de junio de 2026

Finalización primaria (Actual)

20 de junio de 2026

Finalización del estudio (Actual)

23 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

23 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de junio de 2026

Publicado por primera vez (Actual)

6 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data will not be shared because of ethical and institutional restrictions related to patient confidentiality.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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