Postoperative Acute Kidney InjuryNCT05507268
Predictive Nomogram for Postoperative Acute Kidney Injury in Older Patients Undergoing Noncardiac Surgery
An observational study of Postoperative Acute Kidney Injury, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Postoperative acute kidney injury is associated increased risk of morbidity and mortality. Older patients are at high risk of developing postoperative acute kidney injury. However, the incidence and associations of postoperative acute kidney injury in older patients are not well understood. 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
- 50,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 Dec 2022
- 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: Older patients (aged ≥ 65 years) undergoing noncardiac surgery from 2012-2019
Who may be able to join
- Patients aged 65 years and older
Who cannot join
- Emergency operation
- Cardiac surgery
- Incomplete data
- Incomplete data
- Local anesthesia
- Preoperative renal failure or requirement for dialysis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality
Weidong Mi, PhD, 8613381082966, wwdd1962@163.com
Yao Yu, PhD, 8618501088975, 18501088975@163.com
About this study
Postoperative acute kidney injury is associated increased risk of morbidity and mortality. Older patients are at high risk of developing postoperative acute kidney injury. However, the incidence and associations of postoperative acute kidney injury in older patients are not well understood. This study aims to develop and validate a predictive nomogram for postoperative acute kidney injury in older patients undergoing noncardiac surgery.
Read the detailed description
Postoperative acute kidney injury (AKI) affects approximately 2% to 40% of patients undergoing cardiac and major noncardiac surgeries.
Older patients are more susceptible to renal impairment than younger patients. However, the incidence and associations of AKI in older patients are rarely understood.
Generally, in-depth knowledge of risk factors and thus able to identify patients at high risk to develop postoperative AKI is essential to optimize perioperative prevention and protection strategies.
In this retrospective study, the investigators intend to develop and validate a predictive model for postoperative using the identified risk factors.
The primary outcome is postoperative AKI, which according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion, is defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within 7 days after surgery.
- Conditions
- Postoperative Acute Kidney Injury
- Being tested
- no intervention
- Keywords
- prediction model, nomogram, older, noncardiac surgery
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 |
|---|---|---|
| older patients undergoing noncardiac surgery | older patients (aged ≥65 years) scheduled for noncardiac surgery Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury
an absolute increase in serum creatinine of 0.3 mg/dl within 48 hours or a 1.5-fold increase from preoperative baseline within 7 days after surgery
Measured: 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2022
- Study start1 Apr 2022
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 50,000 participants (estimated)
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
- Investigators
- Weidong Mi, PhD, Principal investigator, The First Medical Center of Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507268
- Sponsor's protocol ID
- PLAGH-AOC-004
- Status last verified
- Aug 2022
- First submitted
- 17 Aug 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Nomogram for Postoperative Acute Kidney Injury in Older Patients Undergoing Noncardiac Surgery
- ClinicalTrials.gov ID
- NCT05507268
- Acronym / sponsor ID
- PLAGH-AOC-004
- Conditions
- Postoperative Acute Kidney Injury
- Keywords
- prediction model, nomogram, older, noncardiac surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 18 Aug 2022 (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.
Postoperative acute kidney injury is associated increased risk of morbidity and mortality. Older patients are at high risk of developing postoperative acute kidney injury. However, the incidence and associations of postoperative acute kidney injury in older patients are not well understood. This study aims to develop and validate a predictive nomogram for postoperative acute kidney injury in older patients undergoing noncardiac surgery.
Detailed description
Postoperative acute kidney injury (AKI) affects approximately 2% to 40% of patients undergoing cardiac and major noncardiac surgeries.
Older patients are more susceptible to renal impairment than younger patients. However, the incidence and associations of AKI in older patients are rarely understood.
Generally, in-depth knowledge of risk factors and thus able to identify patients at high risk to develop postoperative AKI is essential to optimize perioperative prevention and protection strategies.
In this retrospective study, the investigators intend to develop and validate a predictive model for postoperative using the identified risk factors.
The primary outcome is postoperative AKI, which according to the Kidney Disease: Improving Global Outcomes (KDIGO) criterion, is defined as an absolute increase in serum creatinine of 0.3 mg/dL within 48 hours or a 1.5-fold increase from preoperative baseline within 7 days after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| older patients undergoing noncardiac surgery | – | Other: no interventionolder patients (aged ≥65 years) scheduled for noncardiac surgery |
Who may qualify
- Ages
- 65 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older patients (aged ≥ 65 years) undergoing noncardiac surgery from 2012-2019
Key inclusion criteria (1 listed)
- Patients aged 65 years and older
Key exclusion criteria (6 listed)
- Emergency operation
- Cardiac surgery
- Incomplete data
- Incomplete data
- Local anesthesia
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 | older patients undergoing noncardiac surgery |
Primary outcome
acute kidney injury
Time frame: 7 days after surgery
an absolute increase in serum creatinine of 0.3 mg/dl within 48 hours or a 1.5-fold increase from preoperative baseline within 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
Weidong Mi, PhD principal investigator
The First Medical Center of Chinese PLA General 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 Postoperative Acute Kidney Injury, run by Chinese PLA General 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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weidong Mi, PhD (8613381082966, wwdd1962@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute kidney injury (time frame: 7 days after 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 18 Aug 2022.