- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05179564
Renal Function Assessment in Critically Ill Children (IOHEXOL)
Comparison of Different Methods to Assess Glomerular Filtration Rate in Critically Ill Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ghent, Belgium
- Ghent University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iohexol plasma clearance
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 |
IV injection of weight-dependent low dose of iohexol at time 0
Other Names:
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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48 hours
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Identify which GFR estimating formulas yield a sufficient accuracy to predict GFR in critically ill children
Time Frame: 48 hours
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of Acute Kidney Injury and Augmented Renal Clearance based on iohexol clearance in critically ill children
Time Frame: 48 hours
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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
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Evelyn Dhont, MD, University Hospital, Ghent
- Principal Investigator: Pieter De Cock, PharmD, University Hospital, Ghent
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B670201835281
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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