Neurological Complications and ICU Workload After Emergency Repair of Acute Type A Aortic Dissection

Completed

• Conditions: Aortic Dissection; Stroke; AKI - Acute Kidney Injury; Coma; Delirium; Paraplegia

• Registration Number: NCT07167628
• Lead Sponsor: China Medical University Hospital

Brief Summary

Single-center retrospective cohort at China Medical University Hospital (Taichung, Taiwan) using fully de-identified electronic health records. Consecutive adults who underwent emergency repair of acute type A aortic dissection between 2021-01-01 and 2025-04-30 were pooled into one cohort. The study measures the incidence and patterns of early postoperative neurological complications and evaluates their association with intensive care unit (ICU) resource use, focusing on prolonged ICU length of stay (LOS ≥ 10 days), ICU and hospital LOS, and duration of mechanical ventilation (MV). No new data collection or patient contact occurs. Institutional Review Board (IRB) approval: CMUH114-REC1-139.

Detailed Description

Adults (≥ 18 years) undergoing emergency repair for acute type A aortic dissection (ATAAD) at China Medical University Hospital (CMUH) during 2021-01-01 to 2025-04-30 were screened. Exclusions: missing key variables, preoperative stroke within 30 days or modified Rankin Scale (mRS) ≥ 4, pregnancy. The analytic cohort included 274 of 309 screened patients. Neurological complications comprise radiology-confirmed stroke, other focal neurological deficits, paraplegia, or sustained coma/encephalopathy recorded by neurology consultation. Prolonged ICU stay is prespecified as ICU LOS ≥ 10 days in the index admission. Outcomes: primary outcomes are prolonged ICU stay and any postoperative neurological complication; secondary outcomes are ICU LOS (days), duration of mechanical ventilation (hours), hospital LOS (days), in-hospital mortality, and 30-day mortality. Analyses are performed in IBM SPSS Statistics version 29. Continuous variables are summarized as medians with interquartile ranges (IQRs) and compared using the Mann-Whitney U test; categorical variables are presented as counts and percentages and compared using chi-square or Fisher exact tests. Multivariable logistic regression identifies factors associated with prolonged ICU stay using a priori covariates (age, sex, chronic kidney disease stage 4-5, operation time, cardiopulmonary bypass \[CPB\] time, intraoperative red blood cell \[RBC\] units transfused, postoperative acute kidney injury \[AKI\], any postoperative neurological complication). Sensitivity analyses repeat the primary model after excluding in-hospital deaths and, separately, treat the endpoint as ICU LOS ≥ 10 days or in-hospital death. Data were de-identified before analysis and stored on secure hospital servers; the study is minimal risk and does not involve United States Food and Drug Administration (US FDA) regulated products.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Study First Submitted: 2025-08-31
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 274

Inclusion Criteria

• Adults (≥18 years) who underwent emergency repair of acute type A aortic dissection at China Medical University Hospital between 2021-01-01 and 2025-04-30.

Exclusion Criteria

• Missing data in key variables required for analyses.
• Preoperative ischemic stroke within 30 days before surgery or preoperative modified Rankin Scale ≥4.
• Pregnancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prolonged ICU length of stay (LOS ≥10 days)	Through ICU discharge during the index admission (up to 30 days).	Proportion of participants with ICU LOS ≥10 days during the index ICU admission. Unit of measure: percent.
Any postoperative neurological complication	Through hospital discharge during the index admission (up to 30 days).	Proportion with stroke (CT/MRI confirmed), other focal neurological deficits, paraplegia, or sustained coma/encephalopathy recorded by neurology consultation. Unit of measure: percent.

Secondary Outcome Measures

Name	Time	Method
ICU length of stay (days)	Through ICU discharge during the index admission (up to 30 days).	ICU LOS summarized as median and IQR; larger values indicate greater resource use. Unit of measure: days.
Duration of mechanical ventilation (hours)	From ICU admission to final extubation (up to 120 hours).	Cumulative hours of invasive ventilation from ICU arrival to final extubation. Unit of measure: hours.
Hospital length of stay (days)	Through hospital discharge during the index admission (up to 30 days).	Days from hospital admission to discharge; deaths counted up to date of death. Unit of measure: days.
30-day mortality	At 30 days after index surgery.	All-cause death within 30 days of the index surgery, whether in or out of hospital. Unit of measure: percent.
In-hospital mortality	Through hospital discharge during the index admission (up to 30 days).	All-cause death before discharge from the index hospitalization. Unit of measure: percent.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung, Taichung City, Taiwan