Renal Function Assessment in Critically Ill Children

Not Applicable

Completed

• Conditions: Critically Ill Children; Acute Kidney Injury; Iohexol; Pharmacokinetics; Renal Function; Augmented Renal Clearance
• Interventions: Diagnostic Test: iohexol administration; Diagnostic Test: iohexol blood sampling

• Registration Number: NCT05179564
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Study Timeline

• Study Start: 2018-05-20
• Study First Submitted: 2019-03-21
• Primary Completion: 2021-02-07
• Study Completion: 2021-02-07
• Status Verified: 2021-10
• Study First Submitted QC: 2021-12-16
• Last Update Submitted: 2021-12-16
• Study First Posted: 2022-01-05
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iohexol plasma clearance	iohexol administration	a weight-dependent dose of iohexol will be injected as an intravenous bolus in 100 patients 2,5 -9kg = 1ml; 10-19kg = 2ml; 20-29kg = 3ml; 30-39kg = 4ml; ≥ 40kg = 5ml
iohexol plasma clearance	iohexol blood sampling	a weight-dependent dose of iohexol will be injected as an intravenous bolus in 100 patients 2,5 -9kg = 1ml; 10-19kg = 2ml; 20-29kg = 3ml; 30-39kg = 4ml; ≥ 40kg = 5ml

Primary Outcome Measures

Name	Time	Method
Agreement between determination of GFR when based on biomarker formulas to estimate GFR compared to measurement of GFR by iohexol plasma clearance	48 hours	* GFR will be calculated by using 26 established mathematical equations based on renal biomarkers; * Iohexol clearance will be calculated from the plasma iohexol disappearance curve based on 3 up to 6 blood samples drawn for iohexol concentration measurement over a 360 minutes interval after iohexol injection, Clearance = iohexol dose /area under the curve; * Agreement between reference method iohexol clearance and estimating GFR formulas will be evaluated by Bland -Altman analysis with determination of bias (= iohexol clearance - estimated GFR), precision (=standard deviation of bias), limits of agreement (= bias +- 1.96 x standard deviation) and visual display of Bland-Altman plots for every eGFR formula
Identify which GFR estimating formulas yield a sufficient accuracy to predict GFR in critically ill children	48 hours	P30 value expresses the percentage of estimated GFR results with evaluated formulas that lie within a 30% range of GFR values measured by iohexol clearance. This P30 value reflects accuracy of a specific GFR estimating formula.; Formulas with P30 \> 75% have acceptable accuracy to be relied on for GFR determination in clinical practice

Secondary Outcome Measures

Name	Time	Method
Prevalence of Acute Kidney Injury and Augmented Renal Clearance based on iohexol clearance in critically ill children	48 hours	AKI will be defined by pediatricRIFLE criteria for GFR decline, using age-specific reference values of GFR; pRIFLE classification of AKI: Risk = GFR decline \> 25% Injury= GFR decline \> 50% Failure= GFR decline \> 75%; ARC will be described as GFR exceeding age-specific reference GFR +2 standard deviations

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium