Clinical trial NCT03946345: Iohexol for Measuring Renal Function
Official title: Iohexol for Measuring Renal Function
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Kidney Injury
Critically Ill Children
Keywords: Iohexol
Glomerular Filtration Rate
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 105
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 105 critically ill children admitted to the pediatric intensive care unit or neonatal intensive care unit from the Radboudumc with at least one failing organ.

Brief summary: Approximately 25-35% of all children admitted to the paediatric intensive care unit (PICU) or neonatal intensive care unit (NICU) will develop Acute Kidney Injury (AKI) during the first seven days after admission. AKI is associated with a worse outcome, including an increased risk of mortality compared to patients without AKI. However, this AKI prevalence estimation is based on serum creatinine based glomerular filtration rate (eGFR), which is known to be inaccurate. The investigators postulate that measured GFR (mGFR) based on iohexol clearance in critically ill children will detect a higher prevalence of children with AKI than currently used methods based on endogenous markers. This study will additionally provide mechanistic knowledge on the relative contribution of GFR and renal transport to renal function in critically ill children.

Detailed description: Primary objective: To determine the prevalence of AKI in critically ill children based on clearance of iohexol.

Secondary objectives:

1. To determine the prevalence of AKI in critically ill children using serum creatinine, creatinine clearance, cystatin C and/or blood urea nitrogen based eGFR equations as well as urinary iohexol clearances.
2. To determine serum Proenkephalin (PENK) levels in critically ill children.
3. To compare the prevalence of AKI when this diagnosis is based on plasma iohexol clearances with the prevalence of AKI based on serum creatinine, creatinine clearance, serum cystatin C, PENK and/or Blood Urea Nitrogen (BUN) based eGFR and to assess agreement between those methods
4. To determine risk factors for the development of AKI when based on iohexol clearance.

Exploratory endpoint: To explore the relationship of genetic variation with the development of AKI.

Eligibility criteria: Inclusion Criteria:

* 0-18 years of postnatal age
* \>37 weeks of gestational age (for infants \< one year postnatal age)
* Bodyweight \>2500g
* Patients admitted to pediatric or neonatal intensive care unit
* PELOD-II (pediatric logistic organ dysfunction score, 2nd version) of 1 or higher (= at least one failing organ)
* Indwelling central line or arterial line in place for clinical purposes, or scheduled regular blood work for clinical reasons (at least once a day)
* Informed written consent

Exclusion Criteria:

* Known medical history of allergic reaction to injection of iodinated contrast material
* Receiving renal replacement therapy
* Language or cognitive inability of parents/caregivers to understand written and oral informed consent.

Primary outcomes:
measure: Prevalence of AKI in critically ill children based on iohexol plasma clearance
timeFrame: 72 hours
Secondary outcomes:
measure: Prevalence of AKI using serum creatinine, creatinine clearance, urinary iohexol, serum cystatin C, serum PENK and/or blood urea nitrogen based eGFR equations.
timeFrame: 72 hours
measure: Serum PENK levels, in relation to iohexol based GFR-measurements in critically ill children.
timeFrame: 72 hours
measure: Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum creatinine levels
timeFrame: 72 hours
measure: Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on creatinine clearance
timeFrame: 72 hours
measure: Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum cystatin C levels
timeFrame: 72 hours
measure: Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum PENK levels
timeFrame: 72 hours
measure: Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on CKiD Schwartz Equation (Serum Creatinine, BUN and Cytatin C)
timeFrame: 72 hours
measure: Risk factors for the development of AKI when based on iohexol clearance.
timeFrame: 72 hours
Other outcomes:
measure: To explore the relationship of genetic variation with the development of AKI.
timeFrame: 72 hours
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: Saskia N De Wildt, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: