Quality Assessment Creatinines in Plasma and Urine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nanne Kleefstra, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT01575392
First received: November 28, 2011
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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.


Condition
Chronic Kidney Disease

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Quality Assessment of Creatinines in Plasma and Urine

Resource links provided by NLM:


Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 months (plasma, urine and dialysate samples are collected only once during the running of the study) ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

All patients presenting at the laboratory facility for a 24-hour creatinine clearance and patients in the dialysis population of the Isala Clinics who came for their periodical KT/V control, were informed about the study and asked to participate. From the 24-hour urine (and for peritoneal dialysis population also from the 24-hour peritoneal dialysate fluid) 4 samples of 4 ml were collected. Moreover, extra blood samples (16 ml in total) were drawn on top of the samples that were necessary for the (routine) 24-hour creatinine clearance.


Enrollment: 181
Study Start Date: June 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients coming for creatinine clearance
For this single group study, all patients presenting at the laboratory facility for a 24-hour creatinine clearance and patients in the dialysis population of the Isala Clinics who came for their periodical KT/V control, were informed about the study and asked to participate. Moreover, 20 'healthy' volunteers (including the investigators of this study and staff working at the clinical chemistry department of the Isala clinics) participated in this study.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

All patients presenting at the laboratory facility for a 24-hour creatinine clearance and patients in the dialysis population of the Isala Clinics who came for their periodical KT/V control, were informed about the study and asked to participate. Moreover, 20 'healthy' volunteers (including the investigators of this study and staff working at the clinical chemistry department of the Isala clinics) participated in this study.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575392

Locations
Netherlands
Isala Clinics
Zwolle, Netherlands
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Investigators
Principal Investigator: I Drion, MD Diabetes Centre, Isala Clinics, Zwolle, the Netherlands
Study Director: Henk JG Bilo, Prof Diabetes Centre, Isala Clinics, Zwolle, the Netherlands
  More Information

No publications provided

Responsible Party: Nanne Kleefstra, ass. professor, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT01575392     History of Changes
Other Study ID Numbers: Krabbe_trial
Study First Received: November 28, 2011
Last Updated: April 10, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Medical Research Foundation, The Netherlands:
creatinine
chronic kidney disease
creatinine clearance
estimated glomerular filtration rate

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 29, 2014