Clinical Values of Automated Electronic Alert for Acute Kidney Injury

February 21, 2023 updated by: XinLing Liang

Clinical Values of Automated Electronic Alert for Acute Kidney injury-a Prospective ,Randomly Controlled Cohort Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prospective, randomly controlled cohort study will be conducted agmong the patients with AKI who are detected by the use of AKI sniffer. The investigators chose to assess all inpatient serum creatinine results using a combination of "KDIGO" criteria.

The investigators randomly divided the patients into two groups:

  1. Usual care : patients will receive standard clinical care by the primary physicians
  2. AKI alert : an AKI alert will be sent to the the doctor in charge. Our team of kidney experts would give a suggestion if the the doctor in charge issue consultation applications.

Study Type

Interventional

Enrollment (Actual)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • Nephrology Dept,Guangdong General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
patients will receive standard clinical care by the doctor in charge.
Experimental: AKI alert
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events during hospitalization
Time Frame: from start of AKI to discharge,up to 4 weeks
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
Time Frame: One year after discharge
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
Time Frame: One year after discharge
AKI recovery/stop renal replacement therapy
One year after discharge
AKI recovery/stop renal replacement therapy
Time Frame: from start of AKI to discharge,up to 4 weeks
Glomerular filtration rate decreased/ new occurrence proteinuria/ original proteinuria aggravation
from start of AKI to discharge,up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of nephrology referral
Time Frame: from start of AKI to discharge,up to 4 weeks
from start of AKI to discharge,up to 4 weeks
Diagnostic rate of AKI at discharge
Time Frame: from start of AKI to discharge,up to 4 weeks
from start of AKI to discharge,up to 4 weeks
Follow-up rate after discharge
Time Frame: One year after discharge
One year after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

XinLing Liang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

June 7, 2016

First Posted (Estimate)

June 8, 2016

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GGH2016-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Kidney Injury

Clinical Trials on AKI alert

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe