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

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Biomarkers in Children
• Intervention / Treatment: 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)

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.

• Study Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University of Basel Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Marc Pfister, Prof. Dr. MD, University of Basel Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Actual): June 5, 2019
• Study Completion (Actual): June 5, 2020

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Cystatin C; Albumin; Uromodulin; Creatinine; Neutrophil gelatinase-associated lipocalin (NGAL); beta-trace Protein; beta-2 Microglobulin
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Cystatins
• Other Study ID Numbers: 2016-00884; ks18Pfister

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No