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Clinical Trials/NCT03751397
NCT03751397
Completed
Not Applicable

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

University Hospital, Basel, Switzerland1 site in 1 country158 target enrollmentDecember 17, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Renal Biomarkers in Children
Sponsor
University Hospital, Basel, Switzerland
Enrollment
158
Locations
1
Primary Endpoint
Serum concentration of cystatin C (mg/l)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 17, 2018
End Date
June 5, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

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))
  • major haemorrhage
  • second or third degree burns
  • liver failure
  • chronic diseases with effecting the kidney (systemic lupus erythematosus, amyloidosis)

Outcomes

Primary Outcomes

Serum concentration of cystatin C (mg/l)

Time Frame: single point in time at subject enrollment

blood test for renal biomarker

Serum concentration of creatinine (ymol/l)

Time Frame: single point in time at subject enrollment

blood test for renal biomarker

Serum concentration of Neutrophil gelatinase-associated lipocalin (ng/ml)

Time Frame: single point in time at subject enrollment

blood test for renal biomarker

Serum concentration of beta-trace Protein (mg/l)

Time Frame: single point in time at subject enrollment

blood test for renal biomarker

Serum concentration of beta-2 Microglobulin (mg/l)

Time Frame: single point in time at subject enrollment

blood test for renal biomarker

Serum concentration of Uromodulin (ng/ml)

Time Frame: single point in time at subject enrollment

blood test for renal biomarker

Urine concentration of creatinine (mmols/kg/24h)

Time Frame: single point in time at subject enrollment

Urine test for renal biomarker

Urine concentration of cystatin C (mg/l)

Time Frame: single point in time at subject enrollment

Urine test for renal biomarker

Urine concentration of Neutrophil gelatinase-associated lipocalin (yg/l)

Time Frame: single point in time at subject enrollment

Urine test for renal biomarker

Urine concentration of beta-trace Protein (mg/l)

Time Frame: single point in time at subject enrollment

Urine test for renal biomarker

Urine concentration of beta-2 microglobulin (mg/l)

Time Frame: single point in time at subject enrollment

Urine test for renal biomarker

Urine concentration of uromodulin (ng/ml)

Time Frame: at time of enrollment

Urine test for renal biomarker

Urine concentration of Albumin (mg/l)

Time Frame: at time of enrollment

Urine test for renal biomarker

Plasma protein binding of survival motor neuron (SMN) 2 splicing modifiers

Time Frame: single point in time at subject enrollment

blood test for spinal muscular atrophy

Study Sites (1)

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