Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associate… (NCT03263325) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of UDP-glucose as a Urinary Biomarker for Early Detection of Cardiac Surgery-associated Pediatric Acute Kidney Injury
United States305 participantsStarted 2017-10-25
Plain-language summary
Acute kidney injury (AKI) is common in children after cardiac surgery with a reported incidence of 20-40%. Pediatric AKI has been found to be associated with important short and long-term adverse outcomes.
A major challenge to management of AKI after cardiac surgery and cardiopulmonary bypass is the lack of early diagnostic markers. Current diagnostic criteria for AKI in children relies exclusively on elevation of serum creatinine concentration and oliguria. Both of these markers lack sensitivity and specificity, and result in delayed detection of kidney injury.
This study aims to determine if UDP-glucose can be used as a urinary biomarker to detect subclinical acute kidney injury following pediatric cardiac surgery with cardiopulmonary bypass.
Who can participate
Age range
8 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* less than or equal to 8 years of age
* scheduled for cardiac surgery
Exclusion Criteria:
* severe pre-existing renal insufficiency
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying a urine marker called UDP-glucose to detect kidney injury earlier in children after heart surgery — if my child is having cardiac surgery, is this kind of biomarker monitoring something that could apply to their care, and is it being measured as part of this study or only for research purposes?
2Since this trial is in a 'not recruiting' phase, does that mean the results are being analyzed soon, and would my child's care team have access to any early findings that might influence how they monitor kidney function after surgery?
3This study focuses on acute kidney injury that happens specifically after cardiac surgery in children — how common is this complication, and what signs would the team be watching for in my child regardless of whether they're part of this trial?
4Since this trial doesn't seem to involve an experimental treatment but rather a new way of detecting kidney injury, what are the current standard methods used to catch AKI early in pediatric cardiac patients, and how might a marker like UDP-glucose improve on those if this research pans out?
5If my child were enrolled in a study like this, would participation involve any additional urine collection procedures or monitoring beyond what's already done after cardiac surgery, and are there any risks or burdens we should be thinking about?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.