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Clinical Trial Summary

Approximately 25-35% of all children admitted to the paediatric intensive care unit (PICU) or neonatal intensive care unit (NICU) will develop Acute Kidney Injury (AKI) during the first seven days after admission. AKI is associated with a worse outcome, including an increased risk of mortality compared to patients without AKI. However, this AKI prevalence estimation is based on serum creatinine based glomerular filtration rate (eGFR), which is known to be inaccurate. The investigators postulate that measured GFR (mGFR) based on iohexol clearance in critically ill children will detect a higher prevalence of children with AKI than currently used methods based on endogenous markers. This study will additionally provide mechanistic knowledge on the relative contribution of GFR and renal transport to renal function in critically ill children.


Clinical Trial Description

Primary objective: To determine the prevalence of AKI in critically ill children based on clearance of iohexol.

Secondary objectives:

1. To determine the prevalence of AKI in critically ill children using serum creatinine, creatinine clearance, cystatin C and/or blood urea nitrogen based eGFR equations as well as urinary iohexol clearances.

2. To determine serum Proenkephalin (PENK) levels in critically ill children.

3. To compare the prevalence of AKI when this diagnosis is based on plasma iohexol clearances with the prevalence of AKI based on serum creatinine, creatinine clearance, serum cystatin C, PENK and/or Blood Urea Nitrogen (BUN) based eGFR and to assess agreement between those methods

4. To determine risk factors for the development of AKI when based on iohexol clearance.

Exploratory endpoint: To explore the relationship of genetic variation with the development of AKI. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03946345
Study type Observational
Source Radboud University
Contact Nori JL Smeets, MD
Phone 0031-24-3614214
Email nori.smeets@radboudumc.nl
Status Recruiting
Phase
Start date May 1, 2019
Completion date April 30, 2021

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