NCT03946345

Iohexol for Measuring Renal Function

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 105 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Kidney Injury
• Critically Ill Children

Interventions

Type	Name	Description
DRUG	Iohexol Inj 300 MG/ML	* Administration of iohexol: each 24 hours one bolus IV (1-5ml) during 72 hours * Blood samples are drawn for analysis of iohexol concentrations and other parameters of renal function at 2, 5 and 7 hours after administration * Urine is collected from catheter between 4 and 6 hours after adminstration to determine urine creatinine and iohexol concentrations

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2019-05-10
• Last updated: 2019-05-10

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated drug study