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临床试验/NCT05409677
NCT05409677已完成不适用

Perioperative Eosinophils And Their Recovery Serve As Prominent Predictors For Type A Acute Aortic Dissection Prognosis

First Affiliated Hospital Xi'an Jiaotong University2 个研究点 分布在 1 个国家目标入组 274 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
274
试验地点
2
主要终点
mortality

研究概览

简要总结

Type A acute aortic dissection (TA-AAD) patients are prone to life-threatening complications and death during the acute phase. Currently, little evidence is available with regards to the relationship between eosinophils (EOS) and TA-AAD.

A total of 274 patients with TA-AAD were eligible for inclusion and 54 patients deceased within 1 month following surgery. Multivariate regression analysis, the general linear model repeated-measures ANOVA analysis (corrected by Greenhouse-Geisser test), receiver-operating characteristics (ROC) curves and a Kaplan-Meier curve were applied for statistical analysis.

详细描述

For this study, 274 patients with TA-AAD admitted into our hospital between February 2019 and July 2021 were enrolled retrospectively. A total of 54 patients deceased unfortunately within 1 month following surgery. We compared baseline sociodemographic, clinical, and functional status based on the main outcome using t tests or Mann-Whitney U test for continuous data and χ2 or Fisher's exact tests for categorical data. Continuous variables were expressed as mean SD median depending on the normality of distribution, and categorical variables were expressed as absolute number along with their percentages and compared using the chi-square test. Multivariate regression analysis was applied to assess the association between EOS and 1-month mortality in an unadjusted model, in an age-, sex-, Body mass index (BMI)-adjusted model (model 2), adjusted for age, sex, BMI, systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial pressure (MAP) (model 3), and further adjusting for age, sex, BMI, SBP, DBP, MAP, heart rate (HR), diabetes, stroke and hyperlipidemia (model 4). In addition, the general linear model repeated-measures ANOVA analysis (Corrected by Greenhouse-Geisser test in nonspherical cases) was used to compare preoperative EOS and postoperative eight-days EOS. For prognostic analysis, receiver-operating characteristics (ROC) curves were used to determine the optimal cutoff of EOS at different points and the time of postoperative EOS to return to normal levels for the prognostic events. A Kaplan-Meier curve was then applied to compare the prognosis between the 2 subgroups based on the predictive threshold. A P value<0.05 was regarded as statistically significant for all statistical tests.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients with a diagnosis of Type A acute aortic dissection by the computer tomography

排除标准

  • History of cardiogenic shock or cardiac tamponade;
  • Iatrogenic aortic dissection;
  • Traumatic aortic dissection;
  • Severe valvular disease;
  • Congenital heart disease;
  • Severe organ dysfunction, such as liver and kidney failure;
  • Metabolic diseases such as gout or hyperthyroidism;
  • Malignant tumor;
  • Severe gastrointestinal diseases;
  • Recent drug usage that might affect EOS;
  • Allergic diseases;
  • Infectious diseases;
  • Skin diseases;
  • Hematological diseases, such as leukemia and myelodysplastic syndromes;
  • Immune system diseases.

结局指标

主要结局

mortality

时间窗: The first month after operation

The primary outcome was 1-month mortality

次要结局

  • Infection and in-hospital poor prognosis(An average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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