Vancomycin-Associated Acute Kidney Injury: A Cross-Sectio... | NCT03456544

Studies
Vancomycin-Associated Acute Kidney Injury: A Cross-Sectional Study From a Multi- Center in China

NCT03456544

Sponsor

Peking University First Hospital

Status

Unknown status

Last Update Posted

Aug 28, 2019Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Vancomycin
Staphylococcal Infections
Adverse Effect
Acute Kidney Injury
Cross-sectional Study

Interventions

Vancomycin

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2018Actual

Primary Completion Date

Oct 31, 2019Estimated

Completion Date

Dec 31, 2019Estimated

First Submitted Date

Feb 1, 2018

First Submission Date that Met QC Criteria

Feb 28, 2018

First Posted Date

Mar 7, 2018Actual

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

Aug 27, 2019

Last Update Posted Date

Aug 28, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Cui Yimin, Chief pharmacist, Peking University First HospitalPrincipal Investigator

Lead Sponsor

Peking University First HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study was to investigate the current situation of vancomycin (VAN)-associated acute kidney injury (VA-AKI) in China and identify the risk factors for VA-AKI, as well as to comprehensively examine the risk related to concurrent drug use. Further, the investigators assessed the outcomes of patients who developed VA-AKI and the risk factors for these outcomes. Finally, the investigators aimed to provide suggestions for improving the prevention and treatment of VA-AKI in China.

Detailed Description

Not provided

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

10,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VAN-AKI		Patients who had vancomycin associated acute kidney injury.	Drug: Vancomycin
None VAN-AKI		Patients who didn't have vancomycin associated acute kidney injury.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vancomycin	Drug	Patients who have vancomycin associated acute kidney injury will be in the Van-AKI group, and those who don't have vancomycin associated acute kidney injury will be in the none VAN-AKI group.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vancomycin-associated acute kidney injury(VAN-AKI) occuration rate		1 year

Secondary Outcomes

Measure	Description	Time Frame
VAN-AKI detection rate		1 year
TDM detction rate		1 year
0h Serum creatinine detction rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Using Vancomycin
≥18 years old

Exclusion Criteria:

Medical records were incomplete
Had been diagnosed with stage 5 CKD or were regularly receiving dialysis
SCr were not being adequately monitored to detect the development of AKI
Had undergone nephrectomy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients who use vancomycin from all centers.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lingyun Ma	Contact	008601066110802		haily618@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University First Hospital	Recruiting	Beijing	Beijing Municipality	100034	China

Condition Browse Module

MeSH Terms

ID	Term
D013203	Staphylococcal Infections
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014640	Vancomycin

Ancestor Terms

ID	Term
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates
D010455	Peptides

Browse Leaves

Not provided

Browse Branches

Not provided