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Iohexol for Measuring Renal Function

NCT03946345 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2019-05-10

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Saskia N De Wildt, MD PhD · Radboud University Medical Center

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-04-30
Completion
2021-04-30
FDA Drug
Yes

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03946345 on ClinicalTrials.gov