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Evaluation of AKI by Measuring the NephroCheck Test After Pediatric Cardiac Surgery

NCT03963284 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 350

Last updated 2019-05-24

No results posted yet for this study

Summary

Blood and urine samples of over 200 pediatric subjects (over 28 days to 3 years) undergoing complex cardiac surgery with cardiopulmonary bypass (CPB) will be collected at several time points to measure corresponding biomarkers such as serum creatinine, serum urea concentration, or NephroCheck test (\[TIMP-2\]\*\[IGFBP7) to evaluate the diagnostic performance of AKI by NephroCheck test .

Conditions

Interventions

PROCEDURE

cardiac surgery

pediatric cardiac surgery with cardiopulmonary bypass

DEVICE

NephroCheck test

Urine of the subjects undergoing cardiac surgery with CPB will be tested by NephroCheck test

Sponsors & Collaborators

  • BioMérieux

    collaborator INDUSTRY

  • Shanghai Children's Medical Center

    lead OTHER

Eligibility

Min Age
28 Days
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-30
Primary Completion
2019-12-31
Completion
2020-06-30
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03963284 on ClinicalTrials.gov