Electronic Alert for Acute Kidney Injury in Geriatric Wards | NCT04464031

Studies
Electronic Alert for Acute Kidney Injury in Geriatric Wards

NCT04464031

Sponsor

Guangdong Provincial People's Hospital

Status

Unknown status

Last Update Posted

Jul 9, 2020Actual

Enrollment

3,000Estimated

Phase

Not Applicable

Conditions

Acute Kidney Injury

Interventions

electronic alert

Countries

Not provided

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Estimated

Primary Completion Date

Aug 1, 2021Estimated

Completion Date

Oct 1, 2021Estimated

First Submitted Date

Jun 16, 2020

First Submission Date that Met QC Criteria

Jul 8, 2020

First Posted Date

Jul 9, 2020Actual

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

Jul 8, 2020

Last Update Posted Date

Jul 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Operating acute kidney injury electronic alert in geriatric wards; Acute authenticity evaluation of acute kidney injury electronic alert; To explore the clinical value of electronic alert for acute kidney injury prevention and treatment in geriatric wards.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Alert group	Experimental		Other: electronic alert
Control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
electronic alert	Other	The e-alert system was developed by the divisions of Nephrology and Information Management of Guangdong Provincial People's Hospital (Patent Application 201610001950.5). The alert system made a diagnosis of acute kidney injury according to Kidney Disease: Improving Global Outcomes criteria. Then, the doctor receives an alert of acute kidney injury.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnosis rate of acute kidney injury (Rate of missed diagnosis);		1 year
Rate of dialysis		1 year
Rate of death		1 year

Secondary Outcomes

Measure	Description	Time Frame
Rate of nephrology consultation		1 year
Rate of nephrology follow-up		1 year
Renal function after 90 days of acute kidney injury

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 65 years old
Diagnose of acute kidney injury by e-alert

Exclusion Criteria:

Baseline serum creatinine > 4mg/dL
Stage-5 chronic kidney disease or maintenance hemodialysis
Kidney transplantation
Amputation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

100 Years

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided