Evaluation of U-AKIpredTM for Predicting AKI in Critically Ill Patients Within 12 Hours: a Multicenter Prospective Cohort Study

July 4, 2024 updated by: tao zhihua, Second Affiliated Hospital, School of Medicine, Zhejiang University
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Critically ill patients

Description

Inclusion Criteria:

  • critically ill patients who stayed in ICU for over 24 h;
  • patients older than 18 years of age.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AKI occurrence
Time Frame: 12 hours
12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 11, 2024

Study Record Updates

Last Update Posted (Actual)

July 11, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-0605

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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