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CompletedNCT07668830Updated Sep 21, 2026

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

An observational study in Aortic Dissection Type A and Acute Kidney Injury Cardiac Surgery, sponsored by Nanjing First Hospital, Nanjing Medical University. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Nanjing First Hospital, Nanjing Medical University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
516
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Aortic Dissection Type A
  • Acute Kidney Injury Cardiac Surgery

Keywords

  • Ankle-Brachial Index
  • Acute Stanford Type A Aortic Dissection
  • Renal Adverse Events
  • Retrospective Cohort Study
  • Arterial Stiffness
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In context

Lead sponsor

Nanjing First Hospital, Nanjing Medical University is the lead sponsor of 213 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population comprised consecutive adults with acute type A aortic dissection who underwent emergency open surgical repair at Nanjing First Hospital, Nanjing Medical University, between January 2019 and February 2024. Eligible patients were identified retrospectively from existing hospital medical records. Inclusion required routine preoperative four-limb cuff pressure measurements sufficient for ABI derivation and postoperative serum creatinine data sufficient for AKI ascertainment. Patients meeting the prespecified exclusion criteria, including ABI ≤0.90, advanced preoperative kidney dysfunction, severe preoperative heart failure, or imaging-confirmed renal or limb malperfusion, were excluded.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
516 participants (actual)
Patient registry
No

Groups and cohorts

  • High Ankle-Brachial Index Group

    Patients with acute type A aortic dissection who underwent emergency surgical repair and had a preoperative cuff-derived ABI \>1.40.

    Other: Preoperative Ankle-Brachial Index

  • Reference Ankle-Brachial Index Group

    Patients with acute type A aortic dissection who underwent emergency surgical repair and had a preoperative cuff-derived ABI \>0.90 and ≤1.40.

    Other: Preoperative Ankle-Brachial Index

Interventions

  • OtherPreoperative Ankle-Brachial Index

    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.

06

What researchers measure

Primary outcomes

  1. Postoperative Acute Kidney Injury

    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.

    Time frame: Within 7 days after surgery

Secondary outcomes

  1. Postoperative Acute Kidney Disease

    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.

    Time frame: Within 7 to 90 days after surgery

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Study locations

1 site
  • Nanjing First Hospital, Nanjing Medical University
    Nanjing, Jiangsu 210006, China
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References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared because this retrospective study uses existing hospital medical records containing sensitive clinical information. Data sharing is restricted by institutional policies and privacy considerations. De-identified aggregate results may be made available in the publication or from the corresponding author upon reasonable request, subject to institutional approval.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07668830
Lead sponsor
Nanjing First Hospital, Nanjing Medical University
Responsible party
Sponsor
First posted
Jun 25, 2026
Start date
Jan 1, 2019
Primary completion
Feb 29, 2024
Completion
Feb 29, 2024
Last update
Sep 21, 2026

Study contacts

Yali Ge
study director · Nanjing First Hospital, Nanjing Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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