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NCT Number: NCT05179564

Renal Function Assessment 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.

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Key information

Conditions

Iohexol Acute Kidney Injury Augmented Renal Clearance Critically Ill Children Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pharmacokinetics Renal Function Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University Hospital

Ghent, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iohexol administration

Diagnostic Test

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

Other names: omnipaque

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

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

Acronym: IOHEXOL

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jan 5, 2022
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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