SurgeryNCT06339229
Postoperative New-onset Proteinuria and Adverse Outcomes.
An observational study of Surgery and Proteinuria, run by Yaozhong Kong.
Trial summary
We aimed to assess the association between postoperative new-onset proteinuria, all-cause mortality, and decline in kidney function in Chinese people who underwent surgery. The exposure variable was the dipstick proteinuria values from the initial postoperative urinalysis within 30 days after surgery, categorized as… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Surgery, Proteinuria, Mortality
- What is being tested?
- proteinuria
- How many people
- 2,983,899 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2000to 1 Nov 2023
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes, participants aged ≥16 years who underwent surgery from January 2000 to December 2022 were included.
Who may be able to join
- surgery patients
Who cannot join
- kidney or urinary surgery
- missing urinalysis results
- dipstick proteinuria indicated a value of "≥ trace" at least once preoperatively
- with dialysis, end-stage renal disease, or with urinary tract infection at baseline
- missing follow-up information
About this study
Official title: Association Between Postoperative New-onset Proteinuria and Adverse Outcomes: a Retrospective Cohort Study.
We aimed to assess the association between postoperative new-onset proteinuria, all-cause mortality, and decline in kidney function in Chinese people who underwent surgery. The exposure variable was the dipstick proteinuria values from the initial postoperative urinalysis within 30 days after surgery, categorized as negative, trace, 1+, and ≥2+. The primary outcome was 30-day mortality. The secondary outcomes included 1-year mortality and composite kidney outcome assessed using the postoperative estimated glomerular filtration rate.
- Conditions
- Surgery, Proteinuria, Mortality
- Being tested
- proteinuria
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proteinuriaOther
dipstick proteinuria values negative, trace, 1+, and ≥2+
| Study group | Role | What they receive |
|---|---|---|
| surgery patients | Not described Receives: Other: proteinuria |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
Measured: 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start1 Jan 2000
- Primary completion31 Dec 2022
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- 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
- 2,983,899 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaozhong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yaozhong Kong, First People's Hospital of Foshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339229
- Sponsor's protocol ID
- FSYYY-2024-12
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Postoperative New-onset Proteinuria and Adverse Outcomes: a Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT06339229
- Acronym / sponsor ID
- FSYYY-2024-12
- Conditions
- Surgery, Proteinuria, Mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,983,899 participants (actual)
- Lead sponsor
- Yaozhong KongUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 1 Apr 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.
We aimed to assess the association between postoperative new-onset proteinuria, all-cause mortality, and decline in kidney function in Chinese people who underwent surgery. The exposure variable was the dipstick proteinuria values from the initial postoperative urinalysis within 30 days after surgery, categorized as negative, trace, 1+, and ≥2+. The primary outcome was 30-day mortality. The secondary outcomes included 1-year mortality and composite kidney outcome assessed using the postoperative estimated glomerular filtration rate.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery patients | – | Other: proteinuria |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes, participants aged ≥16 years who underwent surgery from January 2000 to December 2022 were included.
Key inclusion criteria (1 listed)
- surgery patients
Key exclusion criteria (5 listed)
- kidney or urinary surgery
- missing urinalysis results
- dipstick proteinuria indicated a value of "≥ trace" at least once preoperatively
- with dialysis, end-stage renal disease, or with urinary tract infection at baseline
- missing follow-up information
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 |
|---|---|---|
| proteinuriadipstick proteinuria values negative, trace, 1+, and ≥2+ | Other | surgery patients |
Primary outcome
mortality
Time frame: 30-day
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 1 Apr 2024.
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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 Surgery and Proteinuria, run by Yaozhong Kong.
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 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 1 Apr 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?
mortality (time frame: 30-day). 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 1 Apr 2024.