NCT05179564

Renal Function Assessment in Critically Ill Children

Comparison of Different Methods to Assess Glomerular Filtration Rate in Critically Ill Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Acute kidney injury (AKI) is a frequent comorbidity of critical illness associated with poor outcome, including prolonged duration of mechanical ventilation, longer length of stay and increased mortality or progression to chronic kidney disease on the long term. The reported incidence of AKI in critically ill children and neonates varies widely between 10% and 80% depending on the diagnostic criteria. Besides a decline in renal function, also the phenomenon of augmented renal clearance (ARC) and in consequence enhanced clearance of renally eliminated drugs, is increasingly recognized in pediatric intensive care patients. Hence, accurate assessment of renal function is crucial in the intensive care population to guide therapy. But to date consensus is lacking about the reliability of common GFR estimation methods based on the endogenous renal biomarkers serum creatinine, cystatin C and betatrace protein in critical care patients. the aim of this study is to measure GFR in a reliable way by iohexol plasma clearance and evaluate the agreement between the gold standard technique iohexol plasma clearance and biomarker-based formula to estimate GFR.

Conditions

• Iohexol
• Pharmacokinetics
• Renal Function
• Critically Ill Children
• Acute Kidney Injury
• Augmented Renal Clearance

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	iohexol administration	IV injection of weight-dependent low dose of iohexol at time 0
DIAGNOSTIC_TEST	iohexol blood sampling	Blood sampling will be performed through an arterial (preferred) or venous line, other than the iohexol infusion line. In the first 30 minutes after iohexol injection, a blood sample of 2 ml will be obtained for iohexol concentration measurement and determination of renal biomarkers serum creatinine, cystatin C, betatrace protein. Subsequently, 2 up to 5 additional blood samples of 0,5 ml will be obtained for iohexol determination at 60,120 ,180, 240 and 360 minutes after iohexol injection to calculate iohexol plasma clearance from the plasma disappearance curve

Timeline

• Start date: 2018-05-20
• Primary completion: 2021-02-07
• Completion: 2021-02-07
• First posted: 2022-01-05
• Last updated: 2022-01-05

Locations

1 site across 1 country: Belgium