Perioperative Eosinophils Their Recovery in Type A Acute Aortic Dissection Prognosis

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

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.

Study Overview

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

274

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xian JiaotongUniversity
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xiann JiaotongUniversity

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

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients were dignosed with Type A acute aortic dissection by the computer tomography between February 2019 and July 2021. A total of 54 patients deceased unfortunately within 1 month following surgery. Depending on mortality within 1 month, the baseline characteristics was compared. Patients were 51.58±11.57 years of age, 203(74.1%) men, and 161(58.8%) with hypertension. There was no discernible difference in gender, BMI, smoking, and alcohol consumption (P>0.05). Moreover, in addition to renal insufficiency, medical histories showed no remarkable deviations between the aforementioned two groups. Non-survivors within 1 month were more likely to have renal insufficiency (6.8% vs. 20.4%; P=0.005).

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1-month survivors; 1-month non-survivors
Depending on mortality within 1 month, the patients were divided into two groups named 1-month survivors and 1-month non-survivors.There was no intervention other than normal treatment
This was a retrospective study with no intervention other than normal treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: The first month after operation
The primary outcome was 1-month mortality
The first month after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infection and in-hospital poor prognosis
Time Frame: An average of 1 year
Poor prognosis was defined as development of any adverse event including organ injury, delirium, cerebral infarction, cerebral hemorrhage and other cardiovascular and cerebrovascular complications.
An average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Yang Yan, Doctor, First Affiliated Hospital Xi'an Jiaotong University

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 (ACTUAL)

February 1, 2019

Primary Completion (ACTUAL)

April 6, 2021

Study Completion (ACTUAL)

June 7, 2021

Study Registration Dates

First Submitted

May 25, 2022

First Submitted That Met QC Criteria

June 5, 2022

First Posted (ACTUAL)

June 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 5, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

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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