Iohexol for Measuring Renal Function

NCT03946345 | Unknown FDA Drug

• 1 other identifier: NL68547.091.18
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Critically Ill Children

Keywords

Iohexol; Glomerular Filtration Rate

Outcome Measures

Primary Outcomes (1)

• Prevalence of AKI in critically ill children based on iohexol plasma clearance

  AKI will be defined by using age-specific reference values of GFR. Based on their standard deviations (SD), three groups are defined: * Stage 1: mean -1 SD \> GFR \< mean -1.5 SD * Stage 2: mean -1.5 SD\> GFR \< mean -2 SD * Stage 3: GFR \< mean -2 SD Patients will be grouped according whether they lack AKI or have AKI (either stage 1, 2 or 3). When a patient will be classified as having AKI at one moment and not fulfilling the AKI-criteria at another, or classified into different stages of AKI within one day, the highest stage of the 72 hours will be used for analysis.

  72 hours

Secondary Outcomes (8)

• Prevalence of AKI using serum creatinine, creatinine clearance, urinary iohexol, serum cystatin C, serum PENK and/or blood urea nitrogen based eGFR equations.

  72 hours

• Serum PENK levels, in relation to iohexol based GFR-measurements in critically ill children.

  72 hours

• Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum creatinine levels

  72 hours

• Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on creatinine clearance

  72 hours

• Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum cystatin C levels

  72 hours

Other Outcomes (1)

• To explore the relationship of genetic variation with the development of AKI.

  72 hours

Interventions

Iohexol Inj 300 MG/ML DRUG

* 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

Also known as: OMNIPAQUE 300

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, 6525 GA, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* EDTA plasma samples * Urine samples * Whole blood samples (for future DNA-analysis)

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Iohexol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Saskia N De Wildt, MD PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nori JL Smeets, MD

CONTACT

0031-24-3614214; nori.smeets@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 10, 2019
• Study Start: May 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)