Acute Kidney InjuryNCT07136194
Risk Factors of Postoperative Acute Kidney Injury and Mortality Among Hospitalized Patients Undergoing Major Surgery
An observational study of Acute Kidney Injury and Major Surgery Under General Anesthesia, run by Peking University First Hospital at 1 site in China.
Trial summary
The goal of this retrospective observational study is to learn about the intervenable risk factors of postoperative acute kidney injury (AKI) and in-hospital mortality among adult patients undergoing major surgery. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Kidney Injury, Major Surgery Under General Anesthesia, Mortality
- How many people
- 21,533 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Dec 2020
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive hospitalized adult patients (≥18 years) undergoing major surgery at Peking University First Hospital (PKUFH) between January 1, 2018, and December 31, 2020.
Who may be able to join
- Age≥18 years
- Hospitalized at Peking University First Hospital (PKUFH) between January 1, 2018, and December 31, 2020
- Undergoing major surgery during hospital stay
Who cannot join
- With fewer than two serum creatinine (SCr) measurements during hospitalization, or lack of postoperative SCr assessment
- With pre-exsiting CKD G5 (including long-term dialysis, prior/current kidney transplantation, or baseline estimated glomerular filtration rate [eGFR]<15mL/min/1.73m^2) at admission
- Undergoing radical or partial nephrectomy during current hospitalization
- Developing AKI prior to surgery or within 24 hours after admission (with admission diagnosis of AKI or meeting AKI criteria within 24 hours)
- With hospital stay < 24 hours
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100034
About this study
The goal of this retrospective observational study is to learn about the intervenable risk factors of postoperative acute kidney injury (AKI) and in-hospital mortality among adult patients undergoing major surgery. The main questions it aims to answer are:
- Does preoperative usage of potential nephrotoxic medications (eg., proton pump inhibitor, non-steroidal anti-inflammatory drugs) increase the risk of postoperative AKI and in-hospital mortality?
- Does preoperative status (eg., malnutrition, hypoalbuminemia, hypomagnesemia) increase the risk of postoperative AKI and in-hospital mortality?
- Are there intervenable risk factors of postoperative AKI and in-hospital mortality?
- Are there special risk factors of postoperative AKI and in-hospital mortality in specific patients (eg. elderly, diabetics)? The study will be conducted in retrospective cohort of patients undergoing major surgery. Participants are followed until discharge.
Read the detailed description
Acute Kidney Injury (AKI), characterized by a rapid decline of kidney function, is a common but serious postoperative complication in surgical patients, with an incidence ranging from 5.3% to 18.4%. Postoperative AKI is associated with increased mortality, prolonged hospital stays, and higher medical costs. Survivors are also prone to developing chronic kidney disease (CKD) or even end-stage renal disease (ESRD) . Identifying intervenable risk factors of postoperative AKI can help clinicians develop targeted strategies for high-risk patients.
- Conditions
- Acute Kidney Injury, Major Surgery Under General Anesthesia, Mortality, Postoperative Complication, Risk Factors
- Keywords
- acute kidney injury, major surgery, mortality
- Medical subject headings
- Acute Kidney Injury, Postoperative Complications
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 |
|---|---|---|
| Adult patients undergoing major surgery | Adult patients undergoing major surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative acute kidney injury
Acute kidney injury was defined by the KDIGO criteria. Postoperative AKI referred to acute kidney injury occurring within 7 days after major surgery.
Measured: within 7 days after major surgery
Secondary outcomes (2)
In-hospital acute kidney injury
Acute kidney injury was defined by the KDIGO criteria. In-hospital acute kidney injury referred to acute kidney injury occurring after major surgery before discharge.
Measured: after major surgery until up to 1year
In-hospital mortality
death during hospitalization
Measured: after major surgery until up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start1 Jan 2018
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
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 Peking University First 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
- 21,533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Yang, Peking University First Hospital
- Investigators
- Li Yang, Doctor, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136194
- Sponsor's protocol ID
- 2023-625-002
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets are not publicly available as they are protected by Peking University First Hospital. Access requests should be directed to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Postoperative Acute Kidney Injury and Mortality Among Hospitalized Patients Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT07136194
- Acronym / sponsor ID
- 2023-625-002
- Conditions
- Acute Kidney Injury, Major Surgery Under General Anesthesia, Mortality, Postoperative Complication, Risk Factors
- Keywords
- acute kidney injury, major surgery, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,533 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 22 Aug 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.
The goal of this retrospective observational study is to learn about the intervenable risk factors of postoperative acute kidney injury (AKI) and in-hospital mortality among adult patients undergoing major surgery. The main questions it aims to answer are:
- Does preoperative usage of potential nephrotoxic medications (eg., proton pump inhibitor, non-steroidal anti-inflammatory drugs) increase the risk of postoperative AKI and in-hospital mortality?
- Does preoperative status (eg., malnutrition, hypoalbuminemia, hypomagnesemia) increase the risk of postoperative AKI and in-hospital mortality?
- Are there intervenable risk factors of postoperative AKI and in-hospital mortality?
- Are there special risk factors of postoperative AKI and in-hospital mortality in specific patients (eg. elderly, diabetics)? The study will be conducted in retrospective cohort of patients undergoing major surgery. Participants are followed until discharge.
Detailed description
Acute Kidney Injury (AKI), characterized by a rapid decline of kidney function, is a common but serious postoperative complication in surgical patients, with an incidence ranging from 5.3% to 18.4%. Postoperative AKI is associated with increased mortality, prolonged hospital stays, and higher medical costs. Survivors are also prone to developing chronic kidney disease (CKD) or even end-stage renal disease (ESRD) . Identifying intervenable risk factors of postoperative AKI can help clinicians develop targeted strategies for high-risk patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients undergoing major surgery | – | –Adult patients undergoing major surgery |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive hospitalized adult patients (≥18 years) undergoing major surgery at Peking University First Hospital (PKUFH) between January 1, 2018, and December 31, 2020.
Key inclusion criteria (3 listed)
- Age≥18 years
- Hospitalized at Peking University First Hospital (PKUFH) between January 1, 2018, and December 31, 2020
- Undergoing major surgery during hospital stay
Key exclusion criteria (5 listed)
- With fewer than two serum creatinine (SCr) measurements during hospitalization, or lack of postoperative SCr assessment
- With pre-exsiting CKD G5 (including long-term dialysis, prior/current kidney transplantation, or baseline estimated glomerular filtration rate [eGFR]<15mL/min/1.73m^2) at admission
- Undergoing radical or partial nephrectomy during current hospitalization
- Developing AKI prior to surgery or within 24 hours after admission (with admission diagnosis of AKI or meeting AKI criteria within 24 hours)
- With hospital stay < 24 hours
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
Postoperative acute kidney injury
Time frame: within 7 days after major surgery
Acute kidney injury was defined by the KDIGO criteria. Postoperative AKI referred to acute kidney injury occurring within 7 days after major surgery.
2 secondary outcomes
In-hospital acute kidney injury
Time frame: after major surgery until up to 1year
In-hospital mortality
Time frame: after major surgery until up to 1 year
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 22 Aug 2025.
- Individual participant dataSharing planned: No. The datasets are not publicly available as they are protected by Peking University First Hospital. Access requests should be directed to the principal investigator.
Related trials for Acute Kidney Injury
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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.
Li Yang, Doctor principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Major Surgery Under General Anesthesia, run by Peking University First Hospital at 1 site in China.
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 3 inclusion and 5 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 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Postoperative acute kidney injury (time frame: within 7 days after major surgery). 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 22 Aug 2025.