Acute Kidney InjuryNCT04464031
Electronic Alert for Acute Kidney Injury in Geriatric Wards
A study testing electronic alert in people with Acute Kidney Injury, run by Guangdong Provincial People's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 100 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- electronic alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 1 Oct 2021
- 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 65 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age over 65 years old
- Diagnose of acute kidney injury by e-alert
Who cannot join
- Baseline serum creatinine > 4mg/dL
- Stage-5 chronic kidney disease or maintenance hemodialysis
- Kidney transplantation
- Amputation
About this study
Official title: Study on the Application Value of Electronic Alert for Acute Kidney Injury in Geriatric Wards
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.
- Conditions
- Acute Kidney Injury
- Being tested
- electronic alert
- Keywords
- Acute kidney injury, Alert, Geriatric wards
- 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.
electronic alertOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Alert group | Experimental | Not described Receives: Other: electronic alert |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis rate of acute kidney injury (Rate of missed diagnosis);
Measured: 1 year
Rate of dialysis
Measured: 1 year
Rate of death
Measured: 1 year
Secondary outcomes (3)
Rate of nephrology consultation
Measured: 1 year
Rate of nephrology follow-up
Measured: 1 year
Renal function after 90 days of acute kidney injury
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
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.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04464031
- Sponsor's protocol ID
- 20181015
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Application Value of Electronic Alert for Acute Kidney Injury in Geriatric Wards
- ClinicalTrials.gov ID
- NCT04464031
- Acronym / sponsor ID
- 20181015
- Conditions
- Acute Kidney Injury
- Keywords
- Acute kidney injury, Alert, Geriatric wards
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 9 Jul 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alert group | Experimental | Other: electronic alert |
| Control group | No intervention | – |
Who may qualify
- Ages
- 65 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age over 65 years old
- Diagnose of acute kidney injury by e-alert
Key exclusion criteria (4 listed)
- Baseline serum creatinine > 4mg/dL
- Stage-5 chronic kidney disease or maintenance hemodialysis
- Kidney transplantation
- Amputation
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 |
|---|---|---|
| electronic alertThe 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. | Other | Alert group |
Primary outcome
Diagnosis rate of acute kidney injury (Rate of missed diagnosis);
Time frame: 1 year
Rate of dialysis
Time frame: 1 year
Rate of death
Time frame: 1 year
3 secondary outcomes
Rate of nephrology consultation
Time frame: 1 year
Rate of nephrology follow-up
Time frame: 1 year
Renal function after 90 days of acute kidney injury
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing electronic alert in people with Acute Kidney Injury, run by Guangdong Provincial People's Hospital.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Diagnosis rate of acute kidney injury (Rate of missed diagnosis); (time frame: 1 year). The study lists 3 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 9 Jul 2020.