Acute Kidney InjuryNCT03954353
Effect of Cholesterol Level on Postoperative Acute Kidney Injury of Non-cardiac Surgeries
An observational study of Acute Kidney Injury, run by Peking University First Hospital at 1 site in China.
Trial summary
Preoperative serum cholesterol level may influence occurrence of postoperative acute kidney injury of cardiac surgeries. However, the effect of Preoperative serum cholesterol level for non cardiac surgery remains unknown. This study aimed to explore the effect in non-cardiac surgical population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 78,888 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2019to 6 Jun 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults (age ≥ 18 years old) who underwent elective non-cardiac surgery from January 1, 2012, to December 31, 2017.
Who may be able to join
- adults elective non-cardiac surgery
Who cannot join
- cardiac surgeries kidney surgeries obstetric surgeries local infiltration anesthesia perioperative data missing
Trial locations and contacts
1 site in 1 country.
China1 site
First hospital Peking University
Beijing, Beijing Municipality, 100034
About this study
Preoperative serum cholesterol level may influence occurrence of postoperative acute kidney injury of cardiac surgeries. However, the effect of Preoperative serum cholesterol level for non cardiac surgery remains unknown. This study aimed to explore the effect in non-cardiac surgical population.
- Conditions
- Acute Kidney Injury
- Medical subject headings
- Acute Kidney Injury
What is being measured
The primary outcome is the main question the study is designed to answer.
post-operative acute kidney injury within 30 days in the hospital
It was defined by patient's postoperative serum creatine increase no less than 26.5 μmol/l within 48 hours, or 1.5 times from baseline within the 7 days after surgery or initializing blood dialysis.
Measured: 30 days postoperatively in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start17 May 2019
- Primary completion5 Jun 2019
- Study completion6 Jun 2019
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 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 78,888 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Zhou, MD, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954353
- Sponsor's protocol ID
- ECAKI
- Status last verified
- Jul 2019
- First submitted
- 16 May 2019
- Last updated
- 9 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhou Y, Yang HY, Zhang HL, Zhu XJ. High-density lipoprotein cholesterol concentration and acute kidney injury after noncardiac surgery. BMC Nephrol. 2020 Apr 25;21(1):149. doi: 10.1186/s12882-020-01808-7.
PubMed 32334566
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cholesterol Level on Postoperative Acute Kidney Injury of Non-cardiac Surgeries
- ClinicalTrials.gov ID
- NCT03954353
- Acronym / sponsor ID
- ECAKI
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78,888 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 17 May 2019 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 17 May 2019 (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.
Preoperative serum cholesterol level may influence occurrence of postoperative acute kidney injury of cardiac surgeries. However, the effect of Preoperative serum cholesterol level for non cardiac surgery remains unknown. This study aimed to explore the effect in non-cardiac surgical population.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults (age ≥ 18 years old) who underwent elective non-cardiac surgery from January 1, 2012, to December 31, 2017.
Key inclusion criteria (1 listed)
- adults elective non-cardiac surgery
Key exclusion criteria (1 listed)
- cardiac surgeries kidney surgeries obstetric surgeries local infiltration anesthesia perioperative data missing
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
post-operative acute kidney injury within 30 days in the hospital
Time frame: 30 days postoperatively in hospital
It was defined by patient's postoperative serum creatine increase no less than 26.5 μmol/l within 48 hours, or 1.5 times from baseline within the 7 days after surgery or initializing blood dialysis.
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 9 Jul 2019.
- Derived from this study: PubMed 32334566Zhou Y, Yang HY, Zhang HL, Zhu XJ. High-density lipoprotein cholesterol concentration and acute kidney injury after noncardiac surgery. BMC Nephrol. 2020 Apr 25;21(1):149. doi: 10.1186/s12882-020-01808-7.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 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 9 Jul 2019. 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?
post-operative acute kidney injury within 30 days in the hospital (time frame: 30 days postoperatively in hospital). 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 NCT03954353, 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 9 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.