Clinical trial NCT03751397: Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children.
Official title: Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Biomarkers in Children
Keywords: Creatinine
Albumin
Cystatin C
Neutrophil gelatinase-associated lipocalin (NGAL)
beta-trace Protein
beta-2 Microglobulin
Uromodulin
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 158
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy patients between the age of 0 and 15 years visiting the Short Stay Unit of the University of Basel Children's Hospital for elective surgery and requiring venous access via peripheral venous canula are eligible for study participation

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Serum concentration of creatinine (ymol/l)
timeFrame: single point in time at subject enrollment
measure: Serum concentration of cystatin C (mg/l)
timeFrame: single point in time at subject enrollment
measure: Serum concentration of Neutrophil gelatinase-associated lipocalin (ng/ml)
timeFrame: single point in time at subject enrollment
measure: Serum concentration of beta-trace Protein (mg/l)
timeFrame: single point in time at subject enrollment
measure: Serum concentration of beta-2 Microglobulin (mg/l)
timeFrame: single point in time at subject enrollment
measure: Serum concentration of Uromodulin (ng/ml)
timeFrame: single point in time at subject enrollment
measure: Urine concentration of creatinine (mmols/kg/24h)
timeFrame: single point in time at subject enrollment
measure: Urine concentration of cystatin C (mg/l)
timeFrame: single point in time at subject enrollment
measure: Urine concentration of Neutrophil gelatinase-associated lipocalin (yg/l)
timeFrame: single point in time at subject enrollment
measure: Urine concentration of beta-trace Protein (mg/l)
timeFrame: single point in time at subject enrollment
measure: Urine concentration of beta-2 microglobulin (mg/l)
timeFrame: single point in time at subject enrollment
measure: Urine concentration of uromodulin (ng/ml)
timeFrame: at time of enrollment
measure: Urine concentration of Albumin (mg/l)
timeFrame: at time of enrollment
measure: Plasma protein binding of survival motor neuron (SMN) 2 splicing modifiers
timeFrame: single point in time at subject enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel Children's Hospital
Study officials:
affiliation: University of Basel Children's Hospital
name: Marc Pfister, Prof. Dr. MD
role: PRINCIPAL_INVESTIGATOR
References: