- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06440161
Association of Intraoperative Haemodynamic and Postoperative Complications in Type A Aortic Dissection Surgery
Association of Intraoperative Haemodynamic Instability With Postoperative Mortality, Renal Injury, and Stroke in Type A Aortic Dissection Surgery: A Retrospective Cohort Analysis
Background To determine whether venous congestion is an important predictor of postoperative kidney injury and other adverse events after type A aortic dissection (TAAD).
Methods Authors collected data of adults who underwent surgery for TAAD between January 2016 and July 2023. Primary exposures were venous congestion defined by central venous pressure (CVP) and mean arterial pressure (MAP). The primary outcomes were acute kidney injury (AKI) and acute injury disease (AKD). The secondary outcomes encompassed death and stroke. Restricted cubic spline regression model was used to adjust for confounding factors and multiple comparisons.
Study Overview
Status
Conditions
Detailed Description
Type A aortic dissection (TAAD) is a catastrophic cardiac macrovascular disease with a striking in-hospital mortality rate of 22%-31%. Among the myriad of complications following TAAD surgeries, acute kidney injury (AKI) is one of the most prevalent, boasting an incidence of 40-55%. Notably, this incidence surpasses that observed in other cardiovascular procedures, such as coronary artery bypass grafting (CABG), which ranges from 10-20%, and aortic valve replacement (AVR) at 17-23%. Furthermore, the occurrence of AKI post-TAAD surgeries has been linked with escalated in-hospital, short-term, and long-term mortalities, as well as significant complications.
Preoperatively, patients with TAAD usually have poorly controlled blood pressure, long-term hypertension can cause chronic kidney damage. In some cases, involving renal artery origins, renal perfusion insufficiency may exist preoperatively. Intraoperatively, the kidneys need to undergo a complete ischemic phase of deep hypothermic circulatory arrest (DHCA), inflammatory reactions associated with cardiopulmonary bypass (CPB), and a large number of blood and fluid transfusions could potentially cause renal dysfunction. Patients are at high risk for postoperative surgical site infection following TAAD procedure, further exacerbating acute kidney injury. The myriad factors mentioned above collectively exacerbate the elevated occurrence of kidney injury following Type A Aortic Dissection (TAAD) surgeries when juxtaposed with other cardiac surgical procedures. Pathological anatomy and surgical procedure intricacies pose formidable challenges in mitigation. Consequently, the pursuit of precise intraoperative hemodynamic management objectives aimed at maximizing organ perfusion has emerged as a focal point in contemporary research endeavours. A study encompassing 5,127 patients undergoing CABG and cardiac valvular surgery underscored the role of venous congestion duration and severity as independent postoperative AKI/AKD risk determinants. However, the relationship between intraoperative hemodynamic in TAAD surgeries and ensuing AKI/AKD remains elusive. There's a paucity of comprehensive evaluations, primarily due to a dearth of long-term data from expansive TAAD cohorts. The investigators' primary objective was to discern the correlation between intraoperative hypotension and venous congestion durations and magnitudes at varied thresholds during TAAD surgeries and the subsequent risks of postoperative AKI/AKD. As a secondary objective, the investigators sought to elucidate the association between intraoperative hemodynamic and major adverse events, including stroke and mortality. The investigators hypothesize that both intraoperative hypotension and venous congestion are paramount predictors for postoperative AKI and AKD following TAAD surgeries.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Jiangsu
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Nanjing, Jiangsu, China, 210000
- Nanjing First Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
1) Eligible patients were adults, aged 18 or older.
Exclusion Criteria:
- Lacking preoperative serum creatinine (Scr) values
- Insufficient hemodynamic or laboratory data
- Exhibiting a preoperative Scr level ≥133 μmol/L
- Patients with renal insufficiency before surgery
- Patients on preoperative dialysis
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The Incidence of AKI
Time Frame: After the surgery,up to 7 days
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AKI diagnosis adhered to the Kidney Disease Improvement Global Prognosis Organization (KDIGO) criteria.
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After the surgery,up to 7 days
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The Incidence of AKD
Time Frame: After the surgery,longer than 7 days but within 90 days
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AKD staging was determined based on the Acute Disease Quality Initiative (ADQI) Working Group consensus, using available Scr values from 8 to 90 days post-surgery.
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After the surgery,longer than 7 days but within 90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The days of stay in hospital
Time Frame: perioperatively
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The days of stay in hospital
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perioperatively
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The days of stay in ICU
Time Frame: after surgery
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The days of stay in ICU
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after surgery
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The incidence of in-hospital mortality
Time Frame: after surgery
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The incidence of in-hospital mortality
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after surgery
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The incidence of 30-day all-cause mortality
Time Frame: after surgery
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The incidence of 30-day all-cause mortality
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after surgery
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The incidence of stroke
Time Frame: after surgery
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Stroke diagnosis adhered to National Institute of Neurological Disorders and Stroke rt PA Stroke study Group
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after surgery
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Collaborators and Investigators
Investigators
- Study Director: Ya-li Ge, The First Affiliated Hospital with Nanjing Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency
- Aneurysm
- Aortic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Dissection, Blood Vessel
- Acute Aortic Syndrome
- Acute Kidney Injury
- Aortic Dissection
Other Study ID Numbers
- KY20230918-KS-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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