External Effectiveness Validation of ModelNCT06496555
Evaluation of U-AKIpredTM for Predicting AKI in Critically Ill Patients Within 12 Hours: a Multicenter Prospective Cohort Study
An observational study of External Effectiveness Validation of Model, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of our study is to evaluate U-AKIpredTM for predicting AKI in critically ill patients within 12 h by the multicenter prospective cohorts. AKI was diagnosed by Kidney Disease Improving Global Outcomes (KDIGO) criteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- External Effectiveness Validation of Model
- How many people
- 2,100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 Dec 2025
- How long will I take part?
- 6 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients
Who may be able to join
- critically ill patients who stayed in ICU for over 24 h;
- patients older than 18 years of age.
Who cannot join
- patients who admitted in ICU had been diagnosed acute kidney injury;
- patients who admitted in ICU had been diagnosed acute kidney disease;
- patients who admitted in ICU had been diagnosed chronic kidney disease;
- patients who admitted in ICU had performed kidney dialysis;
- patients who admitted in ICU had performed kidney transplantation;
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Wang Weilin, +86 0571 87783759, keyanlunli_zheer@163.com
About this study
The goal of our study is to evaluate U-AKIpredTM for predicting AKI in critically ill patients within 12 h by the multicenter prospective cohorts. AKI was diagnosed by Kidney Disease Improving Global Outcomes (KDIGO) criteria. We designed five aspects including the overall fitting effecience evaluation, calibration curve, quantifying calibration performance, quantifying discrimination performance, quantifying clinical utility to evaluate the external validation model.
What is being measured
The primary outcome is the main question the study is designed to answer.
AKI occurrence
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start1 Jun 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for External Effectiveness Validation of ModelStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- 2,100 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tao zhihua, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496555
- Sponsor's protocol ID
- 2024-0605
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 11 Jul 2024
- 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 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of U-AKIpredTM for Predicting AKI in Critically Ill Patients Within 12 Hours: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06496555
- Acronym / sponsor ID
- 2024-0605
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 11 Jul 2024 (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.
The goal of our study is to evaluate U-AKIpredTM for predicting AKI in critically ill patients within 12 h by the multicenter prospective cohorts. AKI was diagnosed by Kidney Disease Improving Global Outcomes (KDIGO) criteria. We designed five aspects including the overall fitting effecience evaluation, calibration curve, quantifying calibration performance, quantifying discrimination performance, quantifying clinical utility to evaluate the external validation model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients
Key inclusion criteria (2 listed)
- critically ill patients who stayed in ICU for over 24 h;
- patients older than 18 years of age.
Key exclusion criteria (6 listed)
- patients who admitted in ICU had been diagnosed acute kidney injury;
- patients who admitted in ICU had been diagnosed acute kidney disease;
- patients who admitted in ICU had been diagnosed chronic kidney disease;
- patients who admitted in ICU had performed kidney dialysis;
- patients who admitted in ICU had performed kidney transplantation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AKI occurrence
Time frame: 12 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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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.
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 External Effectiveness Validation of Model, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 2 inclusion and 6 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 11 Jul 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. 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?
Contact Tao Sun, Doctor (0571-87783752, stzr@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AKI occurrence (time frame: 12 hours). 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 11 Jul 2024.