IohexolIOHEXOLNCT05179564
Renal Function Assessment in Critically Ill Children
A study testing iohexol administration and iohexol blood sampling in people with Iohexol and Pharmacokinetics, run by University Hospital, Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Iohexol, Pharmacokinetics, Renal Function
- What is being tested?
- iohexol administration and iohexol blood sampling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 20 May 2018to 7 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Different Methods to Assess Glomerular Filtration Rate in Critically Ill Children
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.
Read the 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
- Being tested
- iohexol administration, iohexol blood sampling
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iohexol administrationDiagnostic test
Also called omnipaque
IV injection of weight-dependent low dose of iohexol at time 0
iohexol blood samplingDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: iohexol administration; Diagnostic Test: iohexol blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 48 hours
Secondary outcomes (1)
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
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start20 May 2018
- Primary completion7 Feb 2021
- Study completion7 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for IohexolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Evelyn Dhont, MD, Principal investigator, University Hospital, GhentPieter De Cock, PharmD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179564
- Sponsor's protocol ID
- B670201835281
- Acronym
- IOHEXOL
- Status last verified
- Oct 2021
- First submitted
- 21 Mar 2019
- Last updated
- 5 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 Mar;65(3):453-463. doi: 10.1007/s40262-025-01617-x. Epub 2026 Jan 27.
PubMed 41591642Dhont 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.
PubMed 37994980Dhont 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.
PubMed 36053381
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Methods to Assess Glomerular Filtration Rate in Critically Ill Children
- ClinicalTrials.gov ID
- NCT05179564
- Acronym / sponsor ID
- IOHEXOL / B670201835281
- Conditions
- Iohexol, Pharmacokinetics, Renal Function, Critically Ill Children, Acute Kidney Injury, Augmented Renal Clearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 20 May 2018 (actual)
- Primary completion
- 7 Feb 2021 (actual)
- Study completion
- 7 Feb 2021 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iohexol plasma clearance | Experimental | Diagnostic Test: iohexol administration, Diagnostic Test: iohexol blood samplinga 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 |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iohexol administrationAlso: omnipaqueIV injection of weight-dependent low dose of iohexol at time 0 | Diagnostic test | iohexol plasma clearance |
| iohexol blood samplingBlood 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 | Diagnostic test | iohexol plasma clearance |
Primary outcome
Agreement between determination of GFR when based on biomarker formulas to estimate GFR compared to measurement of GFR by iohexol plasma clearance
Time frame: 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
Time frame: 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
1 secondary outcome
Prevalence of Acute Kidney Injury and Augmented Renal Clearance based on iohexol clearance in critically ill children
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Derived from this study: PubMed 41591642Dhont 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 Mar;65(3):453-463. doi: 10.1007/s40262-025-01617-x. Epub 2026 Jan 27.
- Derived from this study: PubMed 37994980Dhont 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.
- Derived from this study: PubMed 36053381Dhont 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evelyn Dhont, MD principal investigator
University Hospital, Ghent
Pieter De Cock, PharmD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iohexol administration and iohexol blood sampling in people with Iohexol and Pharmacokinetics, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between determination of GFR when based on biomarker formulas to estimate GFR compared to measurement of GFR by iohexol plasma clearance (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05179564, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.