Iohexol for measuring renal function.

Iohexol for measuring renal function. - HERO-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49710

Enrollment

125

Registered

2019-04-10

Start date

2019-05-17

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney failure loss of renal function

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: 0-18 years of postnatal age >37 weeks of gestational age (for infants 2500g Patients admitted to pediatric or neonatal intensive care unit PELOD-II (pediatric logistic organ dysfunction score) of 1 or higher (

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Prevalence of AKI based on iohexol plasma clearance.	—

Secondary

Measure	Time frame
Secundary study parameters are: 1. Prevalence of AKI in critically ill children using serum creatinine, creatinine clearance, urinary iohexol, serum cystatin C, serum PENK and/or blood urea nitrogen based eGFR equations. 2. Serum PENK levels, in relation to iohexol based GFR-measurements in critically ill children. 3. Difference in prevalence of SCr-AKI, AKI based on creatinine clearance, cysC-AKI, Schwartz-AKI, PENK-AKI and AKI based on urinary iohexol clearances compared with the prevalence of iohexol-AKI and to assess agreement between those methods 4. Risk factors for the development of AKI when based on iohexol clearance. Exploratory studyparameters are: 1. SNPs related to the development of AKI. 2. Performance of GFR1p formula as determined by the developed pop PK model defined by the percentage of GFR determinations that lie within 10% of the reference value (P10). 3. Relation between the clearance of iohexol and GFR determined using endogenous markers in children direct post kidney transplantation as well as in children receiving extra corporeal membrane oxygenation (ECMO).	—

Measure

Time frame

Secundary study parameters are: 1. Prevalence of AKI in critically ill children using serum creatinine, creatinine clearance, urinary iohexol, serum cystatin C, serum PENK and/or blood urea nitrogen based eGFR equations. 2. Serum PENK levels, in relation to iohexol based GFR-measurements in critically ill children. 3. Difference in prevalence of SCr-AKI, AKI based on creatinine clearance, cysC-AKI, Schwartz-AKI, PENK-AKI and AKI based on urinary iohexol clearances compared with the prevalence of iohexol-AKI and to assess agreement between those methods 4. Risk factors for the development of AKI when based on iohexol clearance. Exploratory studyparameters are: 1. SNPs related to the development of AKI. 2. Performance of GFR1p formula as determined by the developed pop PK model defined by the percentage of GFR determinations that lie within 10% of the reference value (P10). 3. Relation between the clearance of iohexol and GFR determined using endogenous markers in children direct post kidney transplantation as well as in children receiving extra corporeal membrane oxygenation (ECMO).

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Countries

Netherlands

Outcome results