NCT03882658

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37,610

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

March 18, 2019

Last Update Submit

May 4, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • incidence and odds ratio of postoperative acute kidney injury

    incidence and odds ratio of postoperative acute kidney injury

    30 days postoperatively in hospital

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult non-cardiac, non-obsteric, non- kidney elective surgery patients

You may qualify if:

  • adult non-cardiac, non-obsteric, non- kidney elective surgery patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First hospital Peking University

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Yan Zhou, MD, PhD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 20, 2019

Study Start

January 10, 2018

Primary Completion

January 20, 2019

Study Completion

February 15, 2019

Last Updated

May 7, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations