Acute Kidney InjuryNCT03119480
Electronic Warning Systems in Diagnosis and Treatment of AKI
An observational study of Acute Kidney Injury, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
To set up electronic early warning system of AKI patients; To develop AKI's intervention, the follow-up process, and the renal physician is responsible for the implementation. To Observe the method after implementing the treatment efficacy of AKI and the differences between the traditional treatment process. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- electronic alerts
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2017to 15 Oct 2018
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: adult patients aged>18 years,with hospital-acquired acute kidney injury, from a university-affiliated hospital in Shanghai, China
Who may be able to join
- Eligible participants were adults aged 18 years or older who were in hospital with stage 1 or greater acute kidney injury as defined by Kidney Disease Improving Global Outcomes creatinine-based criteria.
Who cannot join
- Exclusion criteria were initial hospital creatinine 4•0 mg/dL (to convert to μmol/L, multiply by 88•4) or greater, fewer than two creatinine values measured, inability to determine the covering provider, admission to hospice or the observation unit, previous randomisation, or end-stage renal disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, 200011
About this study
Official title: The Effect of Electronic Warning Systems in the Process of Diagnosis and Treatment of Patients With Acute Kidney Injury
To set up electronic early warning system of AKI patients; To develop AKI's intervention, the follow-up process, and the renal physician is responsible for the implementation.
To Observe the method after implementing the treatment efficacy of AKI and the differences between the traditional treatment process.
Read the detailed description
To set up electronic early warning system according to KDIGO AKI diagnosis standard, real-time monitoring of hospitalized patients with renal function data, real-time detection of AKI patients, notify the diagnosis of renal physician; To develop AKI's intervention, the follow-up process, and the renal physician is responsible for the implementation.
To Observe the method after implementing the treatment efficacy of AKI and the differences between the traditional treatment process.
- Conditions
- Acute Kidney Injury
- Being tested
- electronic alerts
- Keywords
- Acute Kidney Injury, Electronic alerts
- 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 alertsDevice
electronic alerts for AKI
| Study group | Role | What they receive |
|---|---|---|
| Hospital-acquired AKI | Adult patients with Hospital-acquired AKI Receives: Device: electronic alerts |
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
death at 7 days after alert
Measured: at 7 days after alert
Secondary outcomes (2)
dialysis
dialysis at 7 days after alert
Measured: at 7 days after alert
change in creatinine
relative maximum change in creatinine
Measured: at 7 days after alert
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start15 Oct 2017
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
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 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Feng, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Feng Ding, PhD, Study director, Division of Nephrology,Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119480
- Sponsor's protocol ID
- AKI-2017-01
- Status last verified
- Oct 2018
- First submitted
- 13 Apr 2017
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electronic Warning Systems in the Process of Diagnosis and Treatment of Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT03119480
- Acronym / sponsor ID
- AKI-2017-01
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Electronic alerts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 15 Oct 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 18 Apr 2017 (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.
To set up electronic early warning system of AKI patients; To develop AKI's intervention, the follow-up process, and the renal physician is responsible for the implementation.
To Observe the method after implementing the treatment efficacy of AKI and the differences between the traditional treatment process.
Detailed description
To set up electronic early warning system according to KDIGO AKI diagnosis standard, real-time monitoring of hospitalized patients with renal function data, real-time detection of AKI patients, notify the diagnosis of renal physician; To develop AKI's intervention, the follow-up process, and the renal physician is responsible for the implementation.
To Observe the method after implementing the treatment efficacy of AKI and the differences between the traditional treatment process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospital-acquired AKI | – | Device: electronic alertsAdult patients with Hospital-acquired AKI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients aged>18 years,with hospital-acquired acute kidney injury, from a university-affiliated hospital in Shanghai, China
Key inclusion criteria (1 listed)
- Eligible participants were adults aged 18 years or older who were in hospital with stage 1 or greater acute kidney injury as defined by Kidney Disease Improving Global Outcomes creatinine-based criteria.
Key exclusion criteria (1 listed)
- Exclusion criteria were initial hospital creatinine 4•0 mg/dL (to convert to μmol/L, multiply by 88•4) or greater, fewer than two creatinine values measured, inability to determine the covering provider, admission to hospice or the observation unit, previous randomisation, or end-stage renal disease.
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 alertselectronic alerts for AKI | Device | Hospital-acquired AKI |
Primary outcome
all-cause mortality
Time frame: at 7 days after alert
death at 7 days after alert
2 secondary outcomes
dialysis
Time frame: at 7 days after alert
change in creatinine
Time frame: at 7 days after alert
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 17 Oct 2018.
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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.
Feng Ding, PhD study director
Division of Nephrology,Shanghai Ninth People's Hospital, School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University 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 1 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 17 Oct 2018. 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?
all-cause mortality (time frame: at 7 days after alert). 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 17 Oct 2018.