NCT06339229

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,983,899

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
23 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

23 years

First QC Date

March 25, 2024

Last Update Submit

March 25, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • mortality

    30-day

Study Arms (1)

surgery patients

Other: proteinuria

Interventions

dipstick proteinuria values negative, trace, 1+, and ≥2+

surgery patients

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • surgery patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Proteinuria

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 1, 2024

Study Start

January 1, 2000

Primary Completion

December 31, 2022

Study Completion

November 1, 2023

Last Updated

April 1, 2024

Record last verified: 2024-03