Acute Kidney InjuryNCT07080086
The Effect of Preoperative Biological Age on Hemodynamics and Renal Function
An observational study of Acute Kidney Injury and Acute Kidney Disease, run by Nanjing First Hospital, Nanjing Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Kidney Injury, Acute Kidney Disease, Intraoperative Hypotension
- How many people
- 268,833 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 30 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing surgery with complete anaesthetic records
Who may be able to join
- Surgical pateints
Who cannot join
- (1) Lacking valid demographic information; (2) Lacking valid biological age; (3) Lacking blood pressure records
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Kidney Injury, Acute Kidney Disease, Intraoperative Hypotension, Post-induction Hypotension
- Keywords
- Intraoperative Hypotension, post-induction hypotension, Acute Kidney Injury, Acute kidney disease, Biological age, Biological aging
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence ofn AKI
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.
Measured: Within 7 days postoperative,
The incidence of AKD
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.
Measured: Within 8-90 days post-surgery
The incidence of IOH
IOH was defined as the presence of intraoperative epoque with MAP below 60 mmHg.
Measured: During intraoperative period
The incidence of PIH
PIH was defined as at least one measurement of SAP below 90 mmHg.
Measured: From induction of general anesthesia to 20 minutes post-induction.
Secondary outcomes (3)
The incidence of AKI 2+
AKI 2+ was identified as an elevation in SCr to a level at least twice that of the baseline measurement.
Measured: 0-7 days post-surgery
Cumulative duration of IOH and PIH
Calculate the cumulative duration below the threshold value
Measured: During surgery
The cumulative AUC of IOH and PIH.
Total area under each threshold (areas under the curve (AUC) measured in mmHg*minutes).
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Jan 2015
- Primary completion30 Apr 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 268,833 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yali Ge, MD, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080086
- Sponsor's protocol ID
- KY-20240924-09
- Status last verified
- Sep 2023
- First submitted
- 15 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Biological Age on Intraoperative Hemodynamics and Postoperative Renal Function
- ClinicalTrials.gov ID
- NCT07080086
- Acronym / sponsor ID
- KY-20240924-09
- Conditions
- Acute Kidney Injury, Acute Kidney Disease, Intraoperative Hypotension, Post-induction Hypotension
- Keywords
- Intraoperative Hypotension, post-induction hypotension, Acute Kidney Injury, Acute kidney disease, Biological age, Biological aging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268,833 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgery with complete anaesthetic records
Key inclusion criteria (1 listed)
- Surgical pateints
Key exclusion criteria (1 listed)
- (1) Lacking valid demographic information; (2) Lacking valid biological age; (3) Lacking blood pressure records
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence ofn AKI
Time frame: Within 7 days postoperative,
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.
The incidence of AKD
Time frame: Within 8-90 days post-surgery
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.
The incidence of IOH
Time frame: During intraoperative period
IOH was defined as the presence of intraoperative epoque with MAP below 60 mmHg.
The incidence of PIH
Time frame: From induction of general anesthesia to 20 minutes post-induction.
PIH was defined as at least one measurement of SAP below 90 mmHg.
3 secondary outcomes
The incidence of AKI 2+
Time frame: 0-7 days post-surgery
Cumulative duration of IOH and PIH
Time frame: During surgery
The cumulative AUC of IOH and PIH.
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yali Ge, MD study director
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Acute Kidney Disease, run by Nanjing First Hospital, Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence ofn AKI (time frame: Within 7 days postoperative,). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2025.