China Collaborative Study on Epidemiology of Acute Kidney... | NCT03054142

Studies
China Collaborative Study on Epidemiology of Acute Kidney Injury

NCT03054142

Sponsor

XinLing Liang

Status

Recruiting

Last Update Posted

Dec 13, 2022Actual

Enrollment

1,000,000Estimated

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

no intervention

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

First Submitted Date

Feb 13, 2017

First Submission Date that Met QC Criteria

Feb 14, 2017

First Posted Date

Feb 15, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2022

Last Update Posted Date

Dec 13, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

XinLing Liang, Director of Division of Nephrology and Blood Purification Center of Guangdong General Hospital, Guangdong Provincial People's HospitalSponsor-Investigator

Lead Sponsor

XinLing LiangOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Acute kidney injury (AKI) is a common clinical syndrome, especially patients in the hospital. AKI has become a huge medical burden in China. Little information is available about this disease burden in our country. The investigators aimed to evaluate the burden of AKI and to analyze the related risk factors.

Detailed Description

The investigators launch a nationwide of all patients, who were admitted to hospital from 2011-2016. Patients were diagnosed on the basis of changes in serum creatinine by the laboratory information system. The investigators assessed rates of AKI according to the criteria of 2012 Kidney Disease Improving Global Outcomes (KDIGO).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000,000Estimated

Label	Type	Description	Intervention Names
AKI			Other: no intervention
non-AKI			Other: no intervention

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other		AKI non-AKI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of AKI		Jan. 2011 to Oct. 2016

Secondary Outcomes

Measure	Description	Time Frame
Recognition rate of AKI	Using machine learning and deep learning methods to establish AKI prediction model and risk models	Jan. 2011 to Oct. 2016
Proportion of nephrology referral		Jan. 2011 to Oct. 2016

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients diagnosed on the basis of changes in serum creatinine according to the criteria of 2012 Kidney Disease Improving Global Outcomes(KDIGO)

Exclusion Criteria:

Serum creatinine record less than two times during hospitalization
Patients being diagnosed with End-stage kidney disease (chronic kidney disease stage 5)
Nephrectomy
Kidney transplantation
Peak serum creatinine of less than 53µ mol/L
Serum creatinine decrease after amputation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All inpatients (if outpatient identification is achieved, outpatient and inpatient patients can be judged to be the same individual, the outpatient electronic data is extracted at the same time)

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Liang Xinling, M.D.,Ph.D	Contact	13808819770		xinlingliang@139.com
Liang Xinling, M.D.,Ph.D	Contact	86-13808819770		xinlingliang@139.com

Overall Officials

Name	Affiliation	Role
Liang Xinling, M.D.,Ph.D	Nephrology Dept,Guangdong General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nephrology Dept,Guangdong General Hospital	Recruiting	Guangzhou	Guangdong		China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33407184	Derived	Xu L, Wu Y, Chen Y, Li R, Wang Z, Li Z, Liu G, Yu L, Shi W, Liang X; China collaborative study on AKI (CCS-AKI). Is acute kidney injury age-dependent in older adults: an observational study in two centers from North China. BMC Geriatr. 2021 Jan 6;21(1):7. doi: 10.1186/s12877-020-01906-z.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases