- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07080086
- Original Trial
The Effect of Preoperative Biological Age on Hemodynamics and Renal Function
The Effect of Preoperative Biological Age on Intraoperative Hemodynamics and Postoperative Renal Function
Background The aim of this study is to explore the potential value of preoperative biological age as a predictor of intraoperative hemodynamic changes and postoperative renal function injury.
Methods Collect data using medical record system and surgical anesthesia system, and gather patients who have undergone surgery. Calculate the preoperative biological age of the patient and analyze the correlation between preoperative biological age accelerated aging and intraoperative hemodynamics and postoperative renal function damage.
Study Overview
Status
Detailed Description
With the intensification of population aging, the number of patients undergoing surgical procedures has been increasing year by year. However, traditional age indicators cannot fully reflect the physiological condition and surgical risks of patients. In clinical practice, preoperative evaluation is usually based on the patient's actual age, but this method fails to fully consider individual biological differences. As a new evaluation indicator, biological age can more accurately reflect an individual's physiological status and health level by comprehensively considering multiple biomarkers. Therefore, biological age has gradually become one of the important parameters for predicting surgical risk. The stability of intraoperative hemodynamics is crucial for the prognosis of surgical patients. Research has shown that intraoperative blood pressure fluctuations, heart rate variability, and other hemodynamic abnormalities are closely related to the occurrence of postoperative complications. Postoperative renal dysfunction (AKI) is a common and serious postoperative complication, especially more common in elderly patients. Previous studies have found that the occurrence of AKI is not only related to intraoperative hemodynamic disorders, but also significantly influenced by the patient's underlying health status. However, current research on the impact of biological age on intraoperative hemodynamics and its relationship with postoperative renal function injury is still limited. Further exploration of the relationship between preoperative biological age and intraoperative hemodynamic parameters, as well as their predictive value for postoperative renal function injury, will help improve the accuracy of preoperative risk assessment, optimize intraoperative management strategies, and ultimately improve patients' postoperative prognosis. Therefore, this study aims to provide a new predictive tool for clinical practice and a basis for personalized surgical management by systematically evaluating the impact of biological age on intraoperative hemodynamics and postoperative renal function injury.
Based on hospital data, evaluate the hemodynamic fluctuations and incidence of postoperative renal function damage in patients of different biological ages undergoing high-risk surgery. The study aims to verify whether biological age can be independent of traditional clinical evaluation indicators, provide more accurate prediction of perioperative risks for patients, and provide scientific basis for individualized treatment decision-making.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Surgical pateints
Exclusion Criteria:
- (1) Lacking valid demographic information; (2) Lacking valid biological age; (3) Lacking blood pressure records
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Biological age
PhenoAge and Klemera-Doubal method biological age (KDM-BA), were utilized.
PhenoAge was calculated using the combination of chronological age and nine clinical biomarkers (albumin, SCr, glucose, C-reactive protein (CRP), lymphocyte percentage, mean cell volume (MCV), red blood cell distribution width (RDW), alkaline phosphatase, and white blood cell count (WBC)).
KDM-BA was calculated by chronological age and nine clinical biomarkers (albumin, SCr, CRP, alkaline phosphatase, systolic blood pressure, blood urea nitrogen, forced expiratory volume in one second (FEV1), glycated haemoglobin, and total cholesterol).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The incidence ofn AKI
Time Frame: Within 7 days postoperative,
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Pateints encompasses an escalation in SCr of 50% or more, an increment of at least 0.3 mg/dL within 48 hours, or the need for RRT including haemodialysis, peritoneal dialysis, continuous renal replacement therapy, and kidney transplant.
It was based on the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
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Within 7 days postoperative,
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The incidence of AKD
Time Frame: Within 8-90 days post-surgery
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AKD was defined by a surge in SCr by more than 50%, or the initiation of RRT such as haemodialysis, peritoneal dialysis or continuous RRT.
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Within 8-90 days post-surgery
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The incidence of IOH
Time Frame: During intraoperative period
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IOH was defined as the presence of intraoperative epoque with MAP below 60 mmHg.
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During intraoperative period
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The incidence of PIH
Time Frame: From induction of general anesthesia to 20 minutes post-induction.
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PIH was defined as at least one measurement of SAP below 90 mmHg.
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From induction of general anesthesia to 20 minutes post-induction.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The incidence of AKI 2+
Time Frame: 0-7 days post-surgery
|
AKI 2+ was identified as an elevation in SCr to a level at least twice that of the baseline measurement.
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0-7 days post-surgery
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Cumulative duration of IOH and PIH
Time Frame: During surgery
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Calculate the cumulative duration below the threshold value
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During surgery
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The cumulative AUC of IOH and PIH.
Time Frame: During surgery
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Total area under each threshold (areas under the curve (AUC) measured in mmHg*minutes).
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During surgery
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Collaborators and Investigators
Investigators
- Study Director: Yali Ge, MD, 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
Other Study ID Numbers
- KY-20240924-09
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
product manufactured in and exported from the U.S.
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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