Iohexol for Measuring Renal Function

NCT ID: NCT03946345

Last Updated: 2019-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2021-04-30

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.

Conditions

Acute Kidney Injury; Critically Ill Children

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: DRUG

Other Intervention Names

OMNIPAQUE 300

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radboud University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saskia N De Wildt, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Radboud University Medical Center

Locations

Radboudumc

Nijmegen, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Nori JL Smeets, MD

Role: CONTACT

nori.smeets@radboudumc.nl

0031-24-3614214

Facility Contacts

Nori JL Smeets, MD

Role: primary

nori.smeets@radboudumc.nl

0031-24-3614214

Other Identifiers

NL68547.091.18

Identifier Type: -

Identifier Source: org_study_id