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NCT Number: NCT07668830

Preoperative Ankle-Brachial Index and Renal Adverse Events After Acute Type A Aortic Dissection Surgery

This single-centre retrospective observational cohort study evaluated the association between preoperative cuff-derived ankle-brachial index (ABI) and postoperative acute kidney injury (AKI) in adults undergoing emergency repair of acute type A aortic dissection. Existing clinical data from patients treated at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024 were used. High ABI was defined as >1.40, and the reference ABI range was defined as >0.90 and ≤1.40. The primary outcome was creatinine-defined AKI within 7 postoperative days. Exploratory analyses examined whether the association between cumulative intraoperative mean arterial pressure exposure and AKI differed according to ABI phenotype. No intervention or treatment allocation was assigned by the study protocol.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital, Nanjing Medical University

Nanjing, Jiangsu, 210006, China

About this study

This is a single-centre retrospective observational cohort study using routinely collected electronic health records from adults undergoing emergency open repair of acute type A aortic dissection at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024. No study-specific intervention, treatment allocation, or additional clinical follow-up was performed.

The principal exposure was preoperative cuff-derived ankle-brachial index (ABI). ABI was calculated from routine four-limb oscillometric cuff pressures. Each ankle systolic pressure was divided by the higher brachial systolic pressure, and the higher of the two side-specific ABI values was used for patient classification. High ABI was defined as >1.40, and the reference ABI range was defined as >0.90 and ≤1.40. ABI was considered an indirect vascular phenotype marker rather than a direct measure of arterial stiffness or renal autoregulatory reserve.

The primary outcome was postoperative acute kidney injury (AKI) within 7 days, defined using serum creatinine-based Kidney Disease: Improving Global Outcomes criteria. Multivariable regression models were used to evaluate the association between high ABI and postoperative AKI after adjustment for relevant clinical and operative covariates.

Exploratory analyses assessed whether the association between cumulative intraoperative mean arterial pressure (MAP) burden and postoperative AKI differed according to ABI phenotype. Cumulative MAP burden below 65 and 80 mm Hg was evaluated. The candidate haemodynamic thresholds were informed in part by preliminary data exploration; these interaction analyses were therefore considered hypothesis-generating and were not intended to identify physiological or treatment thresholds.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18 years or older with acute type A aortic dissection.
  • Underwent emergency open surgical repair at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024.
  • Routine preoperative four-limb cuff pressure measurements sufficient for calculation of ABI.
  • Postoperative serum creatinine measurements sufficient for ascertainment of AKI.

Exclusion criteria

  • Non-standard or aborted repair, or insufficient intraoperative haemodynamic recordings for the planned analyses.
  • Preoperative estimated glomerular filtration rate <30 ml min-1 1.73 m-2, maintenance dialysis, or end-stage kidney disease.
  • Severe preoperative heart failure, defined as cardiogenic shock, mechanical circulatory support, left ventricular ejection fraction <30%, or New York Heart Association class IV.
  • Previous peripheral or aortic intervention affecting ABI interpretation.
  • Imaging-confirmed renal or limb malperfusion.
  • ABI ≤0.90.
  • For patients with more than one potentially eligible repair during the same admission, only the first eligible repair was included.

Treatment and study plan

Preoperative Ankle-Brachial Index

Other

Preoperative ABI was derived from routine four-limb oscillometric cuff pressure measurements. Each ankle systolic pressure was divided by the higher brachial systolic pressure, and the higher of the two side-specific ABI values was used for patient classification. High ABI was defined as >1.40 and reference ABI as >0.90 and ≤1.40. No intervention was assigned by the study protocol.

Primary outcomes

  1. Postoperative Acute Kidney Injury

    Time frame: Within 7 days after surgery

    Postoperative acute kidney injury was defined according to serum creatinine-based Kidney Disease: Improving Global Outcomes criteria. Acute kidney injury was identified if serum creatinine increased by at least 0.3 mg/dL within 48 hours after surgery or increased to at least 1.5 times the baseline value within 7 days after surgery.

Secondary outcomes

  1. Postoperative Acute Kidney Disease

    Time frame: Within 7 to 90 days after surgery

    Postoperative acute kidney disease was assessed using postoperative renal function data after the acute kidney injury window, according to changes in serum creatinine and renal function during the postoperative period.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Association Between Preoperative Ankle-Brachial Index and Postoperative Renal Adverse Events in Patients With Acute Stanford Type A Aortic Dissection: A Single-Center Retrospective Cohort Study

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Jun 25, 2026
Registry last updated
Sep 21, 2026

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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