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Trial record 11 of 20 for:    Cystatin | Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

Iohexol for Measuring Renal Function (HERO)

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ClinicalTrials.gov Identifier: NCT03946345
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease Intervention/treatment
Acute Kidney Injury Critically Ill Children Drug: Iohexol Inj 300 MG/ML

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.


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Study Type : Observational
Estimated Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Iohexol for Measuring Renal Function
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
Drug Information available for: Iohexol


Intervention Details:
  • 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
    Other Name: OMNIPAQUE 300


Primary Outcome Measures :
  1. Prevalence of AKI in critically ill children based on iohexol plasma clearance [ Time Frame: 72 hours ]

    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.



Secondary Outcome Measures :
  1. Prevalence of AKI using serum creatinine, creatinine clearance, urinary iohexol, serum cystatin C, serum PENK and/or blood urea nitrogen based eGFR equations. [ Time Frame: 72 hours ]

    Classification of AKI based on serum creatinine levels:

    • Stage 1: serum creatinine concentration >150% of median age specific reference value.
    • Stage 2: serum creatinine concentration >200% of median age specific reference value.
    • Stage 3: serum creatinine concentration >300% of median age specific reference value.

    Creatinine clearance: CrCl(ml/min/1.73m2) = (urine volume × urine creatinine × 1.73)/ (serum creatinine × 120 minutes × body surface area)

    AKI classification based on serum cystatin C levels will be similar to classification based on serum creatinine levels

    Urinary iohexol clearance: Ku(X)(t)=dXu/dt & Cl(u)=dXudt/AUCpdt

    AKI will be classified based on eGFR calculated by the CKiD Schwartz Equation

    Data will be analysed for the overall 72 hour period, using the highest grade of AKI during the study duration, as well as per 24 hour period.


  2. Serum PENK levels, in relation to iohexol based GFR-measurements in critically ill children. [ Time Frame: 72 hours ]
  3. Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum creatinine levels [ Time Frame: 72 hours ]
  4. Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on creatinine clearance [ Time Frame: 72 hours ]
  5. Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum cystatin C levels [ Time Frame: 72 hours ]
  6. Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum PENK levels [ Time Frame: 72 hours ]
  7. Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on CKiD Schwartz Equation (Serum Creatinine, BUN and Cytatin C) [ Time Frame: 72 hours ]
  8. Risk factors for the development of AKI when based on iohexol clearance. [ Time Frame: 72 hours ]

Other Outcome Measures:
  1. To explore the relationship of genetic variation with the development of AKI. [ Time Frame: 72 hours ]

Biospecimen Retention:   Samples With DNA
  • EDTA plasma samples
  • Urine samples
  • Whole blood samples (for future DNA-analysis)


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946345


Contacts
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Contact: Nori JL Smeets, MD 0031-24-3614214 nori.smeets@radboudumc.nl

Locations
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Netherlands
Radboudumc Recruiting
Nijmegen, Netherlands, 6525 GA
Contact: Nori JL Smeets, MD    0031-24-3614214    nori.smeets@radboudumc.nl   
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Saskia N De Wildt, MD PhD Radboud University

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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03946345     History of Changes
Other Study ID Numbers: NL68547.091.18
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Radboud University:
Iohexol
Glomerular Filtration Rate
Additional relevant MeSH terms:
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Acute Kidney Injury
Critical Illness
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases