Acute Kidney InjuryNCT03736304
The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients
A study testing AKI alert in people with Acute Kidney Injury and Outcomes, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Acute kidney injury (AKI) is a common disease, but diagnosis is usually delayed or missed in hospitalized patients. The automated electronic alert for AKI may help to improve the outcomes of these patients through identifying all cases of AKI early. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury, Outcomes, Early Diagnosis
- What is being tested?
- AKI alert
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,536 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Jan 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
- Hospitalized adult patients with an Alert for AKI(based on KDIGO guidelines)
Who cannot join
- Patients already having eGFR<15ml/min/1.73m2 or receiving renal replacement therapy for AKI at the time of alert.
- Patients already having a AKI before admission.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients: a Single Center Randomized Controlled Trial.
Acute kidney injury (AKI) is a common disease, but diagnosis is usually delayed or missed in hospitalized patients. The automated electronic alert for AKI may help to improve the outcomes of these patients through identifying all cases of AKI early. Therefore, the investigators conduct a randomly controlled study to test whether automated electronic alert for AKI could improve the outcomes of hospitalized patients.
Read the detailed description
Acute kidney injury (AKI) is a common disease, but diagnosis is usually delayed or missed in hospitalized patients. The automated electronic alert for AKI may help to improve the outcomes of these patients through identifying all cases of AKI early. Therefore, the investigators conduct a randomly controlled study to test whether automated electronic alert for AKI could improve the outcomes of hospitalized patients.
The patients were randomly divided 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 doctor in charge. The team of kidney experts would give a suggestion if the doctor in charge need a renal consultation.
- Conditions
- Acute Kidney Injury, Outcomes, Early Diagnosis
- Being tested
- AKI alert, Usual care
- Medical subject headings
- Acute Kidney Injury, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKI alertDevice
An AKI alert will send to the doctor in charge. The team of nephrologists would give suggestions if the doctor in charge need a renal consultation.
Usual careOther
Patients will receive standard clinical care by the doctor in charge.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | Placebo comparator | Patients will receive standard clinical care by the doctor in charge. Receives: Other: Usual care |
| AKI alert | Experimental | An AKI alert will send to the the doctor in charge. The team of nephrologists would give suggestions if the doctor in charge need a renal consultation. Receives: Device: AKI alert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated glomerular filtration rate changed within 7 days
Medical record
Measured: within 7 days diagnosed with AKI
Secondary outcomes (12)
seven-day mortality
Medical record
Measured: within 7 days diagnosed with AKI
30-day mortality
Medical record
Measured: within 30 days diagnosed with AKI
1-year mortality
telephone follow-up
Measured: within 1 year diagnosed with AKI
receiving renal replacement therapy at seventh day
Medical record
Measured: 7 days
receiving renal replacement therapy at 30th day
telephone follow-up
Measured: 30 days
receiving renal replacement therapy at 1 year
telephone follow-up
Measured: 1 year
the rate of stage 2 AKI
Medical record
Measured: within 7 days diagnosed with AKI
the rate of stage 3 AKI
Medical record
Measured: within 7 days diagnosed with AKI
the rate of AKI recovery at 90 day
telephone follow-up
Measured: 90 days
the rate of timely-recognition of AKI
Medical record
Measured: 3 days
the interventions for AKI
Medical record
Measured: within 7 days diagnosed with AKI
Follow-up rate after discharge
telephone follow-up
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 Nov 2018
- Study start1 Aug 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4,536 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huijuan Mao, PhD,MD, Principal investigator, Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736304
- Sponsor's protocol ID
- 2018-SR-180
- Status last verified
- Dec 2023
- First submitted
- 8 Nov 2018
- Last updated
- 2 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu B, Li L, Cheng X, Yan W, Liu Y, Xing C, Mao H. Propensity-score-matched evaluation of under-recognition of acute kidney injury and short-term outcomes. Sci Rep. 2018 Oct 11;8(1):15171. doi: 10.1038/s41598-018-33103-9.
PubMed 30310097Yang L, Xing G, Wang L, Wu Y, Li S, Xu G, He Q, Chen J, Chen M, Liu X, Zhu Z, Yang L, Lian X, Ding F, Li Y, Wang H, Wang J, Wang R, Mei C, Xu J, Li R, Cao J, Zhang L, Wang Y, Xu J, Bao B, Liu B, Chen H, Li S, Zha Y, Luo Q, Chen D, Shen Y, Liao Y, Zhang Z, Wang X, Zhang K, Liu L, Mao P, Guo C, Li J, Wang Z, Bai S, Shi S, Wang Y, Wang J, Liu Z, Wang F, Huang D, Wang S, Ge S, Shen Q, Zhang P, Wu L, Pan M, Zou X, Zhu P, Zhao J, Zhou M, Yang L, Hu W, Wang J, Liu B, Zhang T, Han J, Wen T, Zhao M, Wang H; ISN AKF 0by25 China Consortiums. Acute kidney injury in China: a cross-sectional survey. Lancet. 2015 Oct 10;386(10002):1465-71. doi: 10.1016/S0140-6736(15)00344-X.
PubMed 26466051Wilson FP, Shashaty M, Testani J, Aqeel I, Borovskiy Y, Ellenberg SS, Feldman HI, Fernandez H, Gitelman Y, Lin J, Negoianu D, Parikh CR, Reese PP, Urbani R, Fuchs B. Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Lancet. 2015 May 16;385(9981):1966-74. doi: 10.1016/S0140-6736(15)60266-5. Epub 2015 Feb 26.
PubMed 25726515Li T, Wu B, Li L, Bian A, Ni J, Liu K, Qin Z, Peng Y, Shen Y, Lv M, Lu X, Xing C, Mao H. Automated Electronic Alert for the Care and Outcomes of Adults With Acute Kidney Injury: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2351710. doi: 10.1001/jamanetworkopen.2023.51710.
PubMed 38241047
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients: a Single Center Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03736304
- Acronym / sponsor ID
- 2018-SR-180
- Conditions
- Acute Kidney Injury, Outcomes, Early Diagnosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,536 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 9 Nov 2018 (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.
Acute kidney injury (AKI) is a common disease, but diagnosis is usually delayed or missed in hospitalized patients. The automated electronic alert for AKI may help to improve the outcomes of these patients through identifying all cases of AKI early. Therefore, the investigators conduct a randomly controlled study to test whether automated electronic alert for AKI could improve the outcomes of hospitalized patients.
Detailed description
Acute kidney injury (AKI) is a common disease, but diagnosis is usually delayed or missed in hospitalized patients. The automated electronic alert for AKI may help to improve the outcomes of these patients through identifying all cases of AKI early. Therefore, the investigators conduct a randomly controlled study to test whether automated electronic alert for AKI could improve the outcomes of hospitalized patients.
The patients were randomly divided 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 doctor in charge. The team of kidney experts would give a suggestion if the doctor in charge need a renal consultation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Placebo comparator | Other: Usual carePatients 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. The team of nephrologists would give suggestions if the doctor in charge need a renal consultation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized adult patients with an Alert for AKI(based on KDIGO guidelines)
Key exclusion criteria (2 listed)
- Patients already having eGFR<15ml/min/1.73m2 or receiving renal replacement therapy for AKI at the time of alert.
- Patients already having a AKI before admission.
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 alertAn AKI alert will send to the doctor in charge. The team of nephrologists would give suggestions if the doctor in charge need a renal consultation. | Device | AKI alert |
| Usual carePatients will receive standard clinical care by the doctor in charge. | Other | Usual care |
Primary outcome
Estimated glomerular filtration rate changed within 7 days
Time frame: within 7 days diagnosed with AKI
Medical record
12 secondary outcomes
seven-day mortality
Time frame: within 7 days diagnosed with AKI
30-day mortality
Time frame: within 30 days diagnosed with AKI
1-year mortality
Time frame: within 1 year diagnosed with AKI
receiving renal replacement therapy at seventh day
Time frame: 7 days
receiving renal replacement therapy at 30th day
Time frame: 30 days
receiving renal replacement therapy at 1 year
Time frame: 1 year
the rate of stage 2 AKI
Time frame: within 7 days diagnosed with AKI
the rate of stage 3 AKI
Time frame: within 7 days diagnosed with AKI
the rate of AKI recovery at 90 day
Time frame: 90 days
the rate of timely-recognition of AKI
Time frame: 3 days
the interventions for AKI
Time frame: within 7 days diagnosed with AKI
Follow-up rate after discharge
Time frame: 1 year
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 2 Jan 2024.
- Background: PubMed 30310097Wu B, Li L, Cheng X, Yan W, Liu Y, Xing C, Mao H. Propensity-score-matched evaluation of under-recognition of acute kidney injury and short-term outcomes. Sci Rep. 2018 Oct 11;8(1):15171. doi: 10.1038/s41598-018-33103-9.
- Background: PubMed 26466051Yang L, Xing G, Wang L, Wu Y, Li S, Xu G, He Q, Chen J, Chen M, Liu X, Zhu Z, Yang L, Lian X, Ding F, Li Y, Wang H, Wang J, Wang R, Mei C, Xu J, Li R, Cao J, Zhang L, Wang Y, Xu J, Bao B, Liu B, Chen H, Li S, Zha Y, Luo Q, Chen D, Shen Y, Liao Y, Zhang Z, Wang X, Zhang K, Liu L, Mao P, Guo C, Li J, Wang Z, Bai S, Shi S, Wang Y, Wang J, Liu Z, Wang F, Huang D, Wang S, Ge S, Shen Q, Zhang P, Wu L, Pan M, Zou X, Zhu P, Zhao J, Zhou M, Yang L, Hu W, Wang J, Liu B, Zhang T, Han J, Wen T, Zhao M, Wang H; ISN AKF 0by25 China Consortiums. Acute kidney injury in China: a cross-sectional survey. Lancet. 2015 Oct 10;386(10002):1465-71. doi: 10.1016/S0140-6736(15)00344-X.
- Background: PubMed 25726515Wilson FP, Shashaty M, Testani J, Aqeel I, Borovskiy Y, Ellenberg SS, Feldman HI, Fernandez H, Gitelman Y, Lin J, Negoianu D, Parikh CR, Reese PP, Urbani R, Fuchs B. Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Lancet. 2015 May 16;385(9981):1966-74. doi: 10.1016/S0140-6736(15)60266-5. Epub 2015 Feb 26.
- Derived from this study: PubMed 38241047Li T, Wu B, Li L, Bian A, Ni J, Liu K, Qin Z, Peng Y, Shen Y, Lv M, Lu X, Xing C, Mao H. Automated Electronic Alert for the Care and Outcomes of Adults With Acute Kidney Injury: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2351710. doi: 10.1001/jamanetworkopen.2023.51710.
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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.
Huijuan Mao, PhD,MD principal investigator
Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University
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 and Outcomes, run by The First Affiliated Hospital with Nanjing Medical 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 2 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 2 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
Estimated glomerular filtration rate changed within 7 days (time frame: within 7 days diagnosed with AKI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03736304, which also lists 4 linked publications.
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 2 Jan 2024.