CompletedNot Applicable

Renal Function Assessment in Critically Ill Children

Belgium100 participantsStarted 2018-05-20

Plain-language summary

Identification of renal dysfunction in critically ill children is often delayed due to lack of accurate methods for evaluation of glomerular filtration rate (GFR). The investigators compared GFR measurement by the gold standard technique iohexol plasma clearance with estimated GFR (eGFR) based on selected established formulas incorporating the renal biomarkers creatinine, cystatin C and betatrace protein.

Who can participate

Age range

15 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: * patients admitted to the pediatric or neonatal intensive care unit * 0 - 15 years * for neonates: gestational age ≥ 37 weeks * bodyweight \>2.5kg * intra-arterial and/or intravenous access available for iohexol administration and blood sampling Exclusion criteria: * no vascular access in place for iohexol administration and blood sampling * absence of parental/patient consent * known hypersensitivity to contrast media or previous history of adverse reaction after administration of contrast agents * known thyroid dysfunction, or for newborns: mother with known thyroid dysfunction * extracorporeal circuit (haemodialysis, extra corporal membrane oxygenation (ECMO), peritoneal dialysis) * patients with chronic kidney disease or congenital kidney anomalies * preterm neonates (gestational age \< 37 weeks) * body weight \< 2.5 kg * dehydrated newborns (i.e. loss of birth weight ≥ 10%) * planned/expected surgery with extracorporeal circulation within 5 days after inclusion

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

Agreement between determination of GFR when based on biomarker formulas to estimate GFR compared to measurement of GFR by iohexol plasma clearance

Timeframe: 48 hours

Identify which GFR estimating formulas yield a sufficient accuracy to predict GFR in critically ill children

Timeframe: 48 hours

Trial details

NCT IDNCT05179564

SponsorUniversity Hospital, Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-07

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