NCT02793167

Brief Summary

Acute kidney injury (AKI) is common, serious and expensive.It is associated with significant mortality, morbidity and increased length of hospital stay.To improve clinical outcomes of AKI by early detection and timely referral to the renal,the investigators developed an electronic alert system which identifies all cases of AKI occurring in patients over 18 years.The system was also designed to collect data on AKI incidence one of the biggest tertiary hospital in China.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

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

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 8, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

5.8 years

First QC Date

May 23, 2016

Last Update Submit

February 21, 2023

Conditions

Keywords

acute kidney injurymedication alert systems

Outcome Measures

Primary Outcomes (4)

  • Adverse events during hospitalization

    cardiac shock/ need for intensive care/ cardiopulmonary resuscitation/ cardiac death/ death

    from start of AKI to discharge,up to 4 weeks

  • Incidence of cardiovascular disease and its occurrence time followed up for 1 years

    heart failure/ acute coronary syndrome/ readmission/cardiac readmission/ cardiovascular intervention or surgery

    One year after discharge

  • The AKI outcome and its occurrence time followed up for 1 years

    AKI recovery/stop renal replacement therapy

    One year after discharge

  • AKI recovery/stop renal replacement therapy

    Glomerular filtration rate decreased/ new occurrence proteinuria/ original proteinuria aggravation

    from start of AKI to discharge,up to 4 weeks

Secondary Outcomes (3)

  • Proportion of nephrology referral

    from start of AKI to discharge,up to 4 weeks

  • Diagnostic rate of AKI at discharge

    from start of AKI to discharge,up to 4 weeks

  • Follow-up rate after discharge

    One year after discharge

Study Arms (2)

Usual care

NO INTERVENTION

patients will receive standard clinical care by the doctor in charge.

AKI alert

EXPERIMENTAL

an AKI alert will send to the the doctor in charge.Our team of nephrologists would give suggestions if the doctor in charge issue consultation application.

Device: AKI alert

Interventions

AKI alertDEVICE
AKI alert

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients with an Alert for AKI(based on KDIGO guidelines)

You may not qualify if:

  • patients already on dialysis for AKI at the time of alert
  • patients with End stage renal disease
  • patients \<18 years of age
  • patients dissenting from participation according to the Ethics application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology Dept,Guangdong General Hospital

Guangzhou, Guangdong, 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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Blood Purification Center of Guangdong General Hospital

Study Record Dates

First Submitted

May 23, 2016

First Posted

June 8, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations