- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07727772
Vascular Aging and Acute Kidney Injury After Cardiac Surgery
Multidimensional Assessment of Vascular Aging and Its Association With Postoperative Acute Kidney Injury in Patients Undergoing Cardiac Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
Acute kidney injury is a common postoperative complication after cardiac surgery and is associated with adverse short-term and long-term outcomes. Vascular aging may reflect systemic vascular dysfunction, impaired vascular compliance, endothelial dysfunction, and reduced renal perfusion reserve, which may increase susceptibility to postoperative acute kidney injury.
This prospective observational cohort study will include adult patients scheduled to undergo cardiac surgery at Nanjing First Hospital, Nanjing Medical University. Perioperative vascular aging-related indicators will be collected according to the study protocol. These indicators may include noninvasive vascular assessments, hemodynamic measurements, and relevant clinical and laboratory variables. Postoperative renal function will be monitored after surgery, and acute kidney injury will be assessed within 7 days after surgery according to predefined diagnostic criteria.
The primary objective is to investigate the association between multidimensional vascular aging markers and the occurrence and severity of postoperative acute kidney injury. Secondary analyses may evaluate the relationships between vascular aging burden and postoperative clinical outcomes, including intensive care unit stay, hospital stay, and other postoperative complications when available. This is an observational study, and no treatment, surgical procedure, or perioperative management strategy will be assigned by the study protocol.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: F Hu
- Phone Number: +8615162614385
- Email: feifanhu0722@foxmail.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210006
- Nanjing First Hospital, Nanjing Medical University
-
Contact:
- Feifan Hu
- Phone Number: +8615162614385
- Email: feifanhu0722@foxmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients aged 18 years or older.
- Patients scheduled to undergo cardiac surgery at Nanjing First Hospital, Nanjing Medical University.
- Patients who are able to provide written informed consent.
- Patients who are expected to undergo perioperative vascular aging assessment and postoperative renal function monitoring according to the study protocol.
Exclusion Criteria:
- Patients younger than 18 years.
- Patients with preoperative end-stage renal disease or maintenance dialysis.
- Patients who are unable to complete the study-specified vascular aging assessment.
- Patients who decline participation or withdraw informed consent.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Cardiac Surgery Cohort
Adult patients undergoing cardiac surgery at Nanjing First Hospital who will receive perioperative vascular aging assessment and postoperative renal function monitoring according to the study protocol.
No treatment or perioperative management strategy will be assigned by the study protocol.
|
Perioperative assessment of vascular aging-related indicators, including noninvasive vascular assessments, hemodynamic measurements, and relevant clinical and laboratory variables.
The assessment is observational and will not determine the treatment, surgical procedure, or perioperative management assigned to participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Postoperative Acute Kidney Injury Within 7 Days After Surgery
Time Frame: From the date of surgery to postoperative day 7
|
Postoperative acute kidney injury will be assessed within 7 days after surgery according to predefined diagnostic criteria based on postoperative renal function changes.
The outcome will be recorded as the occurrence of acute kidney injury during the postoperative 7-day period.
|
From the date of surgery to postoperative day 7
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severity of Postoperative Acute Kidney Injury
Time Frame: From the date of surgery to postoperative day 7
|
The severity of postoperative acute kidney injury will be classified according to predefined staging criteria during the postoperative 7-day period.
|
From the date of surgery to postoperative day 7
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20260625-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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