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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.
Primary objective: To determine the prevalence of AKI in critically ill children based on clearance of iohexol.
Secondary objectives:
Exploratory endpoint: To explore the relationship of genetic variation with the development of AKI.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iohexol Inj 300 MG/ML | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of AKI using serum creatinine, creatinine clearance, urinary iohexol, serum cystatin C, serum PENK and/or blood urea nitrogen based eGFR equations. | Classification of AKI based on serum creatinine levels:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the relationship of genetic variation with the development of AKI. | 72 hours |
Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nori JL Smeets, MD | Contact | 0031-24-3614214 | nori.smeets@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Saskia N De Wildt, MD PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboudumc | Recruiting | Nijmegen | 6525 GA | Netherlands |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D007472 | Iohexol |
| ID | Term |
|---|---|
| D014283 | Triiodobenzoic Acids |
| D007463 | Iodobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
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| 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 |
| Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on serum PENK levels | 72 hours |
| Agreement between diagnosis of AKI when based on iohexol clearance compared to diagnosis based on CKiD Schwartz Equation (Serum Creatinine, BUN and Cytatin C) | 72 hours |
| Risk factors for the development of AKI when based on iohexol clearance. | 72 hours |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |