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

Completed
Conditions
Renal Biomarkers in Children
Registration Number
NCT03751397
Lead Sponsor
University Hospital, Basel, Switzerland
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
158
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Serum concentration of creatinine (ymol/l)single point in time at subject enrollment

blood test for renal biomarker

Serum concentration of cystatin C (mg/l)single point in time at subject enrollment

blood test for renal biomarker

Serum concentration of Neutrophil gelatinase-associated lipocalin (ng/ml)single point in time at subject enrollment

blood test for renal biomarker

Serum concentration of beta-trace Protein (mg/l)single point in time at subject enrollment

blood test for renal biomarker

Serum concentration of beta-2 Microglobulin (mg/l)single point in time at subject enrollment

blood test for renal biomarker

Serum concentration of Uromodulin (ng/ml)single point in time at subject enrollment

blood test for renal biomarker

Urine concentration of creatinine (mmols/kg/24h)single point in time at subject enrollment

Urine test for renal biomarker

Urine concentration of cystatin C (mg/l)single point in time at subject enrollment

Urine test for renal biomarker

Urine concentration of Neutrophil gelatinase-associated lipocalin (yg/l)single point in time at subject enrollment

Urine test for renal biomarker

Urine concentration of beta-trace Protein (mg/l)single point in time at subject enrollment

Urine test for renal biomarker

Urine concentration of beta-2 microglobulin (mg/l)single point in time at subject enrollment

Urine test for renal biomarker

Urine concentration of uromodulin (ng/ml)at time of enrollment

Urine test for renal biomarker

Urine concentration of Albumin (mg/l)at time of enrollment

Urine test for renal biomarker

Plasma protein binding of survival motor neuron (SMN) 2 splicing modifierssingle point in time at subject enrollment

blood test for spinal muscular atrophy

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Basel Children's Hospital

🇨🇭

Basel, Switzerland

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