Acute Kidney InjuryNCT02793167
Clinical Values of Automated Electronic Alert for Acute Kidney Injury
A study testing AKI alert in people with Acute Kidney Injury, run by XinLing Liang at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- AKI alert
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients with an Alert for AKI(based on KDIGO guidelines)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- Usual care : patients will receive standard clinical care by the primary physicians
- 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.
- Conditions
- Acute Kidney Injury
- Being tested
- AKI alert
- Keywords
- acute kidney injury, medication alert systems
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKI alertDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AKI alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events during hospitalization
cardiac shock/ need for intensive care/ cardiopulmonary resuscitation/ cardiac death/ death
Measured: 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
Measured: One year after discharge
The AKI outcome and its occurrence time followed up for 1 years
AKI recovery/stop renal replacement therapy
Measured: One year after discharge
AKI recovery/stop renal replacement therapy
Glomerular filtration rate decreased/ new occurrence proteinuria/ original proteinuria aggravation
Measured: from start of AKI to discharge,up to 4 weeks
Secondary outcomes (3)
Proportion of nephrology referral
Measured: from start of AKI to discharge,up to 4 weeks
Diagnostic rate of AKI at discharge
Measured: from start of AKI to discharge,up to 4 weeks
Follow-up rate after discharge
Measured: One year after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2021
- Study completionJun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- XinLing Liang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, XinLing Liang, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793167
- Sponsor's protocol ID
- GGH2016-1
- Status last verified
- Feb 2023
- First submitted
- 23 May 2016
- Last updated
- 23 Feb 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Values of Automated Electronic Alert for Acute Kidney injury-a Prospective ,Randomly Controlled Cohort Study
- ClinicalTrials.gov ID
- NCT02793167
- Acronym / sponsor ID
- GGH2016-1
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injury, medication alert systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- XinLing LiangUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Dec 2021 (actual)
- Study completion
- Jun 2022 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Usual care : patients will receive standard clinical care by the primary physicians
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –patients will receive standard clinical care by the doctor in charge. |
| AKI alert | Experimental | Device: AKI alertan 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients with an Alert for AKI(based on KDIGO guidelines)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKI alert | Device | AKI alert |
Primary outcome
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
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
The AKI outcome and its occurrence time followed up for 1 years
Time frame: One year after discharge
AKI recovery/stop renal replacement therapy
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
3 secondary outcomes
Proportion of nephrology referral
Time frame: 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
Follow-up rate after discharge
Time frame: One year after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AKI alert in people with Acute Kidney Injury, run by XinLing Liang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events during hospitalization (time frame: from start of AKI to discharge,up to 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.