Quality Assessment Creatinines in Plasma and Urine

Chronic Kidney Disease Clinical Trial

Official title:

Quality Assessment of Creatinines in Plasma and Urine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575392
• Other study ID #: Krabbe_trial
• Status: Completed
• Phase: N/A
• First received: November 28, 2011
• Last updated: April 10, 2012
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: April 2012
• Source: Medical Research Foundation, The Netherlands
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

In clinical practice the 24-hour creatinine clearance is often used to obtain an impression of renal function. However, the glomerular filtration rate is considered to be the best indicator of renal function. For practical and financial purposes, GFR is often estimated by means of serum creatinine based equations. These equations are also used in internation guidelines to define and classify chronic kidney disease. Therefore, accurate creatinine measurements are important to make reliable estimates of renal function. However, previous research has revealed a large variability in creatinine measurements using different measuring methods. In this study the investigators aim to establish the degree of variability in different methods to measure creatinine in a heterogenous group of Caucasian people with and without renal function loss and the influence of this variability on renal function estimating equations and the 24-hour creatinine clearance.

Description:

Apart from the 24-hour creatinine clearance, also formulas to estimate the glomerular filtration rate (GFR) are increasingly used to get an impression from renal function in recent years. Based on these renal function measurements, clinical decisions are made as well as drug dose adjustments. The use of reliable serum creatinine measurements is therefore important to get accurate renal function estimates. However, serum creatinine is one of the most variable routine laboratory tests.

The importance of calibration to a traceable reference measurement of serum creatinine has been stressed. However, this standardization does not correct for analytical non-specificity problems, which occurs in certain techniques to measure creatinine, leading to under- or overestimation of the true creatinine concentration.

The aim of this cross-sectional observational study is to examine the degree of variability between diverse methods to measure creatinine in plasma and urine in a heterogenous group of Caucasian people with and without renal function loss and the influence hereof on the 24-hour creatinine clearance and the Modification of Diet in Renal Disease study equation and the consequences for chronic kidney disease staging.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients >18 years presenting at the laboratory facility for a 24-hour creatinine clearance, or

• Persons >18 years, undergoing a renal replacing therapy by means of hemo-/peritoneal dialysis that had a KT/V appointment between May 2010 - January 2011

Exclusion Criteria:

• Patients <18 years

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
Netherlands	Isala Clinics	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Foundation, The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the bias and precision between routine laboratory techniques to measure creatinine in plasma, urine and dialysate when compared to the gold standard to measure creatinine.	Creatinine concentrations of plasma, urine and/or dialysate samples will be measured using different techniques applied in daily clinical practice (jaffe, enzymatic and HPLC). For each participant creatinine will also be measured using the gold standard measure LC-MS. LCMS values will be used as reference method against which routine methods will be compared by means of absolute bias and precision per method group. Absolute bias is the mean difference between SCr values measured by individual laboratories and SCr target values; precision is defined as the SD of the absolute bias.	6 months (plasma, urine and dialysate samples are collected only once during the running of the study)	No