Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children.

Study Overview
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Brief Summary
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To characterize the relationship of renal biomarkers (Creatinine, albumin, Cystatin C, NGAL, beta-trace protein, beta-2 microglobulin, and uromodulin) between each other and the variation over age, measured in serum and urine of healthy children. Unused residual blood and urine samples will be used for testing the renal Parameters.

Detailed Description
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Despite relevant research in renal biomarkers, there is currently no optimal marker available that reliably quantifies kidney function and indicates kidney injury in its early stages. The combination of two or more biomarkers might be a more promising approach than investigating a single parameter. The relationship of renal biomarkers (creatinine, albumin, Cystatin C, NGAL, beta-trace protein, beta-2 microglobulin, and uromodulin) between each other and the variation over age in infants and children (without chronic kidney disease) is investigated. The biomarkers in urine samples are explored to find less invasive means of quantifying renal health. Patients between the age of 0 and 12 years undergoing blood with or without urine sampling as part of their diagnostic workup are eligible for the study. Unused residual blood and urine samples will be used for testing the renal parameters.

Official Title
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Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children

Conditions
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Renal Biomarkers in Children

Intervention / Treatment
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* Other: blood test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein, beta-2 microglobulin, uromodulin)
* Other: urine test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein beta-2 microglobulin, uromodulin, albumin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy patients for elective surgery, requiring venous access via peripheral venous canula Exclusion Criteria: chronic kidney disease acute kidney failure (stage 2 or above as defined by Kidney Disease Improving Global Outcomes (KDIGO) consensus 2012)) sepsis shock major haemorrhage second or third degree burns liver failure chronic diseases with effecting the kidney (systemic lupus erythematosus, amyloidosis)

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: blood test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein, beta-2 microglobulin, uromodulin)|relationship between the different biomarkers by linear regression analysis is assessed; influence of demographic variables (age, body weight, body surface area) is investigated by multivariate regression.|
|Other: urine test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein beta-2 microglobulin, uromodulin, albumin)|relationship between the different biomarkers by linear regression analysis is assessed; influence of demographic variables (age, body weight, body surface area) is investigated by multivariate regression.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration of creatinine (ymol/l) | blood test for renal biomarker | single point in time at subject enrollment | 
| Serum concentration of cystatin C (mg/l) | blood test for renal biomarker | single point in time at subject enrollment | 
| Serum concentration of Neutrophil gelatinase-associated lipocalin (ng/ml) | blood test for renal biomarker | single point in time at subject enrollment | 
| Serum concentration of beta-trace Protein (mg/l) | blood test for renal biomarker | single point in time at subject enrollment | 
| Serum concentration of beta-2 Microglobulin (mg/l) | blood test for renal biomarker | single point in time at subject enrollment | 
| Serum concentration of Uromodulin (ng/ml) | blood test for renal biomarker | single point in time at subject enrollment | 
| Urine concentration of creatinine (mmols/kg/24h) | Urine test for renal biomarker | single point in time at subject enrollment | 
| Urine concentration of cystatin C (mg/l) | Urine test for renal biomarker | single point in time at subject enrollment | 
| Urine concentration of Neutrophil gelatinase-associated lipocalin (yg/l) | Urine test for renal biomarker | single point in time at subject enrollment | 
| Urine concentration of beta-trace Protein (mg/l) | Urine test for renal biomarker | single point in time at subject enrollment | 
| Urine concentration of beta-2 microglobulin (mg/l) | Urine test for renal biomarker | single point in time at subject enrollment | 
| Urine concentration of uromodulin (ng/ml) | Urine test for renal biomarker | at time of enrollment | 
| Urine concentration of Albumin (mg/l) | Urine test for renal biomarker | at time of enrollment | 
| Plasma protein binding of survival motor neuron (SMN) 2 splicing modifiers | blood test for spinal muscular atrophy | single point in time at subject enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uromodulin, Creatinine, Albumin, Cystatin C, Neutrophil gelatinase-associated lipocalin (NGAL), beta-trace Protein, beta-2 Microglobulin