Acute Kidney InjuryNCT03882658
Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury
An observational study of Acute Kidney Injury, run by Peking University First Hospital at 1 site in China.
Trial summary
Acute kidney injury is one of major adverse postoperative complications. research about postoperative acute kidney injury conclude that low preoperative albumin and intraoperative hypotension is associated to postoperative acute kidney injury. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 37,610 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2018to 15 Feb 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult non-cardiac, non-obsteric, non- kidney elective surgery patients
Who may be able to join
- adult non-cardiac, non-obsteric, non- kidney elective surgery patients
Who cannot join
- patients aged <18 y emergency surgeries without arterial blood pressure cardiac surgeries obstetric surgeries kidney surgeries under local infiltration or MAC first SBP <100 mmHg
Trial locations and contacts
1 site in 1 country.
China1 site
First hospital Peking University
Beijing, Beijing Municipality, 100034
About this study
Official title: Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury: a Retrospective Cohort Analysis
Acute kidney injury is one of major adverse postoperative complications. research about postoperative acute kidney injury conclude that low preoperative albumin and intraoperative hypotension is associated to postoperative acute kidney injury. However, due to ethic issue and nonlinear realtionship between these factors and postoperative acute kidney injury, the exact threshold of these two risk factors were not be able to identified. The research tried to locate the exact threshold with implementation of penalized splines by generalized additive model.
- 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.
incidence and odds ratio of postoperative acute kidney injury
incidence and odds ratio of postoperative acute kidney injury
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 posted20 Mar 2019
- Study start10 Jan 2018
- Primary completion20 Jan 2019
- Study completion15 Feb 2019
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
- 37,610 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
- Investigators
- Yan Zhou, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882658
- Sponsor's protocol ID
- ALBHYTAKI
- Status last verified
- May 2019
- First submitted
- 18 Mar 2019
- Last updated
- 7 May 2019
- 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 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Serum Albumin and Duration of Intraoperative Hypotension on Postoperative Acute Kidney Injury: a Retrospective Cohort Analysis
- ClinicalTrials.gov ID
- NCT03882658
- Acronym / sponsor ID
- ALBHYTAKI
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37,610 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 20 Mar 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.
Acute kidney injury is one of major adverse postoperative complications. research about postoperative acute kidney injury conclude that low preoperative albumin and intraoperative hypotension is associated to postoperative acute kidney injury. However, due to ethic issue and nonlinear realtionship between these factors and postoperative acute kidney injury, the exact threshold of these two risk factors were not be able to identified. The research tried to locate the exact threshold with implementation of penalized splines by generalized additive model.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult non-cardiac, non-obsteric, non- kidney elective surgery patients
Key inclusion criteria (1 listed)
- adult non-cardiac, non-obsteric, non- kidney elective surgery patients
Key exclusion criteria (1 listed)
- patients aged <18 y emergency surgeries without arterial blood pressure cardiac surgeries obstetric surgeries kidney surgeries under local infiltration or MAC first SBP <100 mmHg
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
incidence and odds ratio of postoperative acute kidney injury
Time frame: 30 days postoperatively in hospital
incidence and odds ratio of 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 7 May 2019.
- Individual participant dataSharing planned: No
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Acute Kidney Injury, Hypotension (MeSH: D007022)
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.
Yan Zhou, MD, PhD 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, 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 7 May 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?
incidence and odds ratio of postoperative acute kidney injury (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?
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 7 May 2019.