Postoperative Acute Kidney InjuryNCT06462755
Perioperative Database of Chinese Elderly Patients for Postoperative Acute Kidney Injury
An observational study of Postoperative Acute Kidney Injury, run by Chinese PLA General Hospital.
Trial summary
To develop and externally validate a risk prediction model for postoperative acute kidney injury (PO-AKI) in elderly patients undergoing major noncardiac surgery, addressing the current gap in predictive tools for this vulnerable population. Read more about this study
- Who is it for?
- Ages 65 to 120 years
- Conditions the study is for
- Postoperative Acute Kidney Injury
- How many people
- 57,089 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 31 Dec 2018
- 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 65 to 120 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients (aged ≥ 65 years) undergoing non-cardiac surgeries
Who may be able to join
- elderly patients (aged ≥ 65 years) undergoing non-cardiac surgeries
Who cannot join
- (1) Patients who underwent endoscopic or transplant procedures;
- (2) Patients who underwent surgeries lasting longer than 10 hours;
- (3) Patients who had severe preoperative kidney dysfunction, defined as preoperative sCr levels ≥ 353.6 μmol/L, or a baseline estimated Glomerular Filtration Rate (eGFR) < 15 ml/min per 1.73 m2;
- (4) Patients without sCr values at baseline or during follow-up to detect PO-AKI occurrences.
About this study
To develop and externally validate a risk prediction model for postoperative acute kidney injury (PO-AKI) in elderly patients undergoing major noncardiac surgery, addressing the current gap in predictive tools for this vulnerable population.
The endpoint was the occurrence of PO-AKI within seven days following surgery. Diagnoses were based on the Kidney Disease: Improving Global Outcomes (KDIGO) criterion. Potential PO-AKI-related perioperative data were retrieved and extracted from electronic medical record for model derivation and validation.
Clinicians may consider implementing this externally validated risk prediction model to stratify elderly patients' PO-AKI risks in the early postoperative phases of noncardiac surgery in elderly patients.
- Conditions
- Postoperative Acute Kidney Injury
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| elderly patients (aged ≥ 65 years) | elderly patients undergo surgeries Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative acute kidney injury
Postoperative acute kidney injury
Measured: within seven days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jan 2009
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- 57,089 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weidong Mi, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462755
- Sponsor's protocol ID
- PLAGH-AOC-R01
- Status last verified
- Jul 2024
- First submitted
- 12 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang X, Ruan X, Yu Y, Sun T, Zhang J, Cong X, Lou J, Li H, Cao J, Liu Y, Mi W. Development with external validation of a prediction model for postoperative acute kidney injury following noncardiac surgery in elderly patients. BMC Geriatr. 2025 May 30;25(1):390. doi: 10.1186/s12877-025-06023-3.
PubMed 40447991
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Database of Chinese Elderly Patients for Postoperative Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT06462755
- Acronym / sponsor ID
- PLAGH-AOC-R01
- Conditions
- Postoperative Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57,089 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 17 Jun 2024 (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.
To develop and externally validate a risk prediction model for postoperative acute kidney injury (PO-AKI) in elderly patients undergoing major noncardiac surgery, addressing the current gap in predictive tools for this vulnerable population.
The endpoint was the occurrence of PO-AKI within seven days following surgery. Diagnoses were based on the Kidney Disease: Improving Global Outcomes (KDIGO) criterion. Potential PO-AKI-related perioperative data were retrieved and extracted from electronic medical record for model derivation and validation.
Clinicians may consider implementing this externally validated risk prediction model to stratify elderly patients' PO-AKI risks in the early postoperative phases of noncardiac surgery in elderly patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly patients (aged ≥ 65 years) | – | Other: No interventionelderly patients undergo surgeries |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients (aged ≥ 65 years) undergoing non-cardiac surgeries
Key inclusion criteria (1 listed)
- elderly patients (aged ≥ 65 years) undergoing non-cardiac surgeries
Key exclusion criteria (4 listed)
- (1) Patients who underwent endoscopic or transplant procedures;
- (2) Patients who underwent surgeries lasting longer than 10 hours;
- (3) Patients who had severe preoperative kidney dysfunction, defined as preoperative sCr levels ≥ 353.6 μmol/L, or a baseline estimated Glomerular Filtration Rate (eGFR) < 15 ml/min per 1.73 m2;
- (4) Patients without sCr values at baseline or during follow-up to detect PO-AKI occurrences.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionno intervention | Other | elderly patients (aged ≥ 65 years) |
Primary outcome
Number of participants with postoperative acute kidney injury
Time frame: within seven days following surgery
Postoperative acute kidney injury
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 8 Jul 2024.
- Derived from this study: PubMed 40447991Zhang X, Ruan X, Yu Y, Sun T, Zhang J, Cong X, Lou J, Li H, Cao J, Liu Y, Mi W. Development with external validation of a prediction model for postoperative acute kidney injury following noncardiac surgery in elderly patients. BMC Geriatr. 2025 May 30;25(1):390. doi: 10.1186/s12877-025-06023-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Acute Kidney Injury, run by Chinese PLA General Hospital.
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 4 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 8 Jul 2024. 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?
Number of participants with postoperative acute kidney injury (time frame: within seven days following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06462755, which also lists 1 linked publication.
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 8 Jul 2024.