Perioperative Eosinophils Their Recovery in Type A Acute Aortic Dissection Prognosis

Acute Aortic Dissection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05409677
• Other study ID #: 81871607
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: June 7, 2021

Study information

• Verified date: May 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: June 7, 2021
• Est. primary completion date: April 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Aortic Dissection
• Aneurysm, Dissecting

Intervention

Other:
• This was a retrospective study with no intervention other than normal treatment
This was a retrospective study with no intervention other than normal treatment

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xian JiaotongUniversity	Xi'an	Shaanxi
China	First Affiliated Hospital of Xiann JiaotongUniversity	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	The primary outcome was 1-month mortality	The first month after operation
Secondary	Infection and in-hospital poor prognosis	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