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

Renal Biomarkers in Children Clinical Trial

— KidMaCare  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03751397
• Other study ID #: 2016-00884; ks18Pfister
• Status: Completed
• Start date: December 17, 2018
• Est. completion date: June 5, 2020

Study information

• Verified date: July 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: June 5, 2020
• Est. primary completion date: June 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Renal Biomarkers in Children

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	University of Basel Children's Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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