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Aortic DissectionATAAD-ICUNCT07167628

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

An observational study of Aortic Dissection and Stroke, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Dissection, Stroke, Paraplegia
How many people
274 participants
Where
1 siteTaiwan
Study dates
1 Jan 2021to 30 Apr 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive adults undergoing emergency repair of acute type A aortic dissection at a single tertiary centre ICU in Taichung, Taiwan (2021-01-01 to 2025-04-30).

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • China Medical University Hospital

    Taichung, Taichung City, 40447

Other trials in Taiwan

About this study

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

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.

Read the 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 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.

Keywords
Acute type A aortic dissection, Neurological complications, Intensive care unit, ICU workload, ICU length of stay, Mechanical ventilation, Hospital length of stay, Retrospective cohort, Nursing workload, Taiwan
Medical subject headings
Aortic Dissection, Stroke, Paraplegia, Acute Kidney Injury, Coma, Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07167628
Study groupRoleWhat they receive
Adults undergoing emergency ATAAD repairSingle-center retrospective cohort of consecutive 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; all participants are pooled into one cohort with no protocol-assigned interventions; outcomes are obtained from de-identified records to assess neurological complications and ICU resource use.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Proportion of participants with ICU LOS ≥10 days during the index ICU admission. Unit of measure: percent.

    Measured: Through ICU discharge during the index admission (up to 30 days).

  2. Any postoperative neurological complication

    Proportion with stroke (CT/MRI confirmed), other focal neurological deficits, paraplegia, or sustained coma/encephalopathy recorded by neurology consultation. Unit of measure: percent.

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

Secondary outcomes (5)
  1. ICU length of stay (days)

    ICU LOS summarized as median and IQR; larger values indicate greater resource use. Unit of measure: days.

    Measured: Through ICU discharge during the index admission (up to 30 days).

  2. Duration of mechanical ventilation (hours)

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

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

  3. Hospital length of stay (days)

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

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

  4. In-hospital mortality

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

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

  5. In-hospital mortality within 30 days

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study start1 Jan 2021
  3. Primary completion30 Apr 2025
  4. Study completion30 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07167628
Sponsor's protocol ID
CMUH114-REC1-139
Acronym
ATAAD-ICU
Status last verified
Dec 2025
First submitted
31 Aug 2025
Last updated
26 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. The dataset consists of de-identified electronic health records governed by CMUH institutional policy and IRB approval (CMUH114-REC1-139), which restrict external transfer. Aggregate results or summary tables may be provided on reasonable request, subject to additional REC approval and data-use agreements.

Publications

  • Vandenbroucke JP, von Elm E, Altman DG, Gotzsche PC, Mulrow CD, Pocock SJ, Poole C, Schlesselman JJ, Egger M; STROBE Initiative. Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): explanation and elaboration. PLoS Med. 2007 Oct 16;4(10):e297. doi: 10.1371/journal.pmed.0040297.

    PubMed 17941715
  • Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available.

    PubMed 22890468
  • Sacco RL, Kasner SE, Broderick JP, Caplan LR, Connors JJ, Culebras A, Elkind MS, George MG, Hamdan AD, Higashida RT, Hoh BL, Janis LS, Kase CS, Kleindorfer DO, Lee JM, Moseley ME, Peterson ED, Turan TN, Valderrama AL, Vinters HV; American Heart Association Stroke Council, Council on Cardiovascular Surgery and Anesthesia; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular and Stroke Nursing; Council on Epidemiology and Prevention; Council on Peripheral Vascular Disease; Council on Nutrition, Physical Activity and Metabolism. An updated definition of stroke for the 21st century: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013 Jul;44(7):2064-89. doi: 10.1161/STR.0b013e318296aeca. Epub 2013 May 7.

    PubMed 23652265
  • Queijo AF, Martins RS, Andolhe R, Oliveira EM, Barbosa RL, Padilha KG. Nursing workload in neurological intensive care units: cross-sectional study. Intensive Crit Care Nurs. 2013 Apr;29(2):112-6. doi: 10.1016/j.iccn.2012.08.001. Epub 2012 Sep 19.

    PubMed 22999497
  • Branch-Elliman W, Wright SB, Gillis JM, Howell MD. Estimated nursing workload for the implementation of ventilator bundles. BMJ Qual Saf. 2013 Apr;22(4):357-61. doi: 10.1136/bmjqs-2012-001372. Epub 2013 Feb 21.

    PubMed 23431219
  • Lewis K, Balas MC, Stollings JL, McNett M, Girard TD, Chanques G, Kho ME, Pandharipande PP, Weinhouse GL, Brummel NE, Chlan LL, Cordoza M, Duby JJ, Gelinas C, Hall-Melnychuk EL, Krupp A, Louzon PR, Tate JA, Young B, Jennings R, Hines A, Ross C, Carayannopoulos KL, Aldrich JM. A Focused Update to the Clinical Practice Guidelines for the Prevention and Management of Pain, Anxiety, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2025 Mar 1;53(3):e711-e727. doi: 10.1097/CCM.0000000000006574. Epub 2025 Feb 21.

    PubMed 39982143
  • Liu H, Zhang S, Zhang C, Gao Q, Liu Y, Liao F, Ge S. Risk factors for prolonged postoperative ICU stay in the patients with Stanford type A aortic dissection. J Cardiothorac Surg. 2024 Feb 3;19(1):46. doi: 10.1186/s13019-024-02548-7.

    PubMed 38310273
  • Dumfarth J, Kofler M, Stastny L, Plaikner M, Krapf C, Semsroth S, Grimm M. Stroke after emergent surgery for acute type A aortic dissection: predictors, outcome and neurological recovery. Eur J Cardiothorac Surg. 2018 May 1;53(5):1013-1020. doi: 10.1093/ejcts/ezx465.

    PubMed 29360972
  • Biancari F, Herve A, Peterss S, Radner C, Buech J, Pettinari M, Rodriguez Lega J, Pinto AG, Fiore A, Onorati F, Francica A, Wisniewski K, Demal T, Conradi L, Rocek J, Kacer P, Gatti G, Vendramin I, Rinaldi M, Ferrante L, Pruna-Guillen R, Quintana E, DI Perna D, Mariscalco G, Jormalainen M, Field M, Harky A, Dell'aquila AM, Juvonen T, Makikallio T, Perrotti A. Predictors, prognosis and costs of prolonged intensive care unit stay after surgery for type A aortic dissection. Minerva Anestesiol. 2024 Jul-Aug;90(7-8):654-661. doi: 10.23736/S0375-9393.24.18210-7.

    PubMed 39021141
  • Arabi YM, Phua J, Koh Y, Du B, Faruq MO, Nishimura M, Fang WF, Gomersall C, Al Rahma HN, Tamim H, Al-Dorzi HM, Al-Hameed FM, Adhikari NK, Sadat M; Asian Critical Care Clinical Trials Group. Structure, Organization, and Delivery of Critical Care in Asian ICUs. Crit Care Med. 2016 Oct;44(10):e940-8. doi: 10.1097/CCM.0000000000001854.

    PubMed 27347762

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Dissection and Stroke, run by China Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prolonged ICU length of stay (LOS ≥10 days) (time frame: Through ICU discharge during the index admission (up to 30 days).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07167628, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.

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