Quality Assessment Creatinines in Plasma and Urine

NCT01575392 | Completed

• 1 other identifier: Krabbe_trial
• Study Type: observational
• Target: 181
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Kidney Disease

Keywords

creatinine; chronic kidney disease; creatinine clearance; estimated glomerular filtration rate

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients \<18 years

Sponsors & Collaborators

• Medical Research Foundation, The Netherlands: lead

Study Sites (1)

Isala Clinics

Zwolle, Netherlands

Location

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.

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• I Drion, MD

  Diabetes Centre, Isala Clinics, Zwolle, the Netherlands

  PRINCIPAL INVESTIGATOR

• Henk JG Bilo, Prof

  Diabetes Centre, Isala Clinics, Zwolle, the Netherlands

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ass. professor

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: April 11, 2012
• Study Start: June 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: April 11, 2012

Record last verified: 2012-04

Locations

NL (1)