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NCT Number: NCT07167628

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

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.

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Key information

Conditions

Aortic Dissection AKI - Acute Kidney Injury Acute Aortic Syndrome Acute Kidney Injury Aneurysm Aortic Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Coma Confusion Consciousness Disorders Delirium Dissection, Blood Vessel Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Paralysis Paraplegia Pathological Conditions, Signs and Symptoms Renal Insufficiency Signs and Symptoms Stroke Unconsciousness Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China Medical University Hospital

Taichung, Taichung City, 40447, Taiwan

About this study

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 in-hospital death within 30 days of the index surgery. Analyses are performed in R version 4.5.1. 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 (ICU LOS ≥ 10 days) among hospital survivors 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). A prespecified sensitivity analysis in the full cohort treats the endpoint as ICU LOS ≥ 10 days or in-hospital death using the same prespecified covariates. 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prolonged ICU length of stay (LOS ≥10 days)

    Time frame: 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.

  2. Any postoperative neurological complication

    Time frame: 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 outcomes

  1. ICU length of stay (days)

    Time frame: 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.

  2. Duration of mechanical ventilation (hours)

    Time frame: Through final extubation during the index hospitalization (up to 40 days).

    Cumulative hours of invasive ventilation from ICU arrival to final extubation. Unit of measure: hours.

  3. Hospital length of stay (days)

    Time frame: Through hospital discharge during the index admission (up to 65 days).

    Days from hospital admission to discharge; deaths counted up to date of death. Unit of measure: days.

  4. In-hospital mortality

    Time frame: Through hospital discharge during the index admission (up to 30 days).

    All-cause death before discharge from the index hospitalization. Unit of measure: percent.

  5. In-hospital mortality within 30 days

    Time frame: Up to 30 days after index surgery, during the index hospitalization.

    All-cause death occurring during the index hospitalization within 30 days after the index surgery (deaths after hospital discharge were not captured).

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

Neurological Complications and Intensive-Care Workload After Emergency Repair of Acute Type A Aortic Dissection: A Retrospective Cohort Study

Acronym: ATAAD-ICU

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 11, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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