Renal Function Assessment in Critically Ill Children

NCT05179564 | Completed

• 1 other identifier: B670201835281
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Prevalence of Acute Kidney Injury and Augmented Renal Clearance based on iohexol clearance in critically ill children

  48 hours

Study Arms (1)

iohexol plasma clearance

EXPERIMENTAL

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

Diagnostic Test: iohexol administration; Diagnostic Test: iohexol blood sampling

Interventions

iohexol administration DIAGNOSTIC_TEST

IV injection of weight-dependent low dose of iohexol at time 0

Also known as: omnipaque

iohexol plasma clearance

iohexol blood sampling DIAGNOSTIC_TEST

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

iohexol plasma clearance

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients admitted to the pediatric or neonatal intensive care unit
• years
• for neonates: gestational age ≥ 37 weeks
• bodyweight \>2.5kg
• intra-arterial and/or intravenous access available for iohexol administration and blood sampling

You may not qualify if:

• 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%)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University Hospital

Ghent, Belgium

Location

Related Publications (3)

• Dhont E, Destere A, Gerard A, Bouveyron C, Snauwaert E, Vanhaesebrouck S, De Paepe P, Woillard JB, De Cock P. Accurate Estimation of Glomerular Filtration Rate in Critically Ill Infants and Children Using a Iohexol Population Pharmacokinetic Modeling Approach. Clin Pharmacokinet. 2026 Jan 27. doi: 10.1007/s40262-025-01617-x. Online ahead of print.

  PMID: 41591642 DERIVED

• Dhont E, Van Der Heggen T, Snauwaert E, Willems J, Croubels S, Delanghe J, De Waele JJ, Colman R, Vande Walle J, De Paepe P, De Cock PA. Predictors of augmented renal clearance based on iohexol plasma clearance in critically ill children. Pediatr Nephrol. 2024 May;39(5):1607-1616. doi: 10.1007/s00467-023-06221-4. Epub 2023 Nov 23.

  PMID: 37994980 DERIVED

• Dhont E, Windels C, Snauwaert E, Van Der Heggen T, de Jaeger A, Dhondt L, Delanghe J, Croubels S, Walle JV, De Paepe P, De Cock PA. Reliability of glomerular filtration rate estimating formulas compared to iohexol plasma clearance in critically ill children. Eur J Pediatr. 2022 Nov;181(11):3851-3866. doi: 10.1007/s00431-022-04570-0. Epub 2022 Sep 2.

  PMID: 36053381 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Evelyn Dhont, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Pieter De Cock, PharmD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: January 5, 2022
• Study Start: May 20, 2018
• Primary Completion: February 7, 2021
• Study Completion: February 7, 2021
• Last Updated: January 5, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)