Renal Function Assessment in Critically Ill Children

Acute Kidney Injury Clinical Trial

— IOHEXOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05179564
• Other study ID #: B670201835281
• Status: Completed
• Phase: N/A
• Start date: May 20, 2018
• Est. completion date: February 7, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 7, 2021
• Est. primary completion date: February 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• iohexol administration
IV injection of weight-dependent low dose of iohexol at time 0
• 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

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between determination of GFR when based on biomarker formulas to estimate GFR compared to measurement of GFR by iohexol plasma clearance	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	48 hours
Primary	Identify which GFR estimating formulas yield a sufficient accuracy to predict GFR in critically ill children	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	48 hours
Secondary	Prevalence of Acute Kidney Injury and Augmented Renal Clearance based on iohexol clearance in critically ill children	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	48 hours